Portable ultrasound technology has revolutionized point-of-care imaging by providing clinicians with handheld devices that can plug into smartphones or tablets for on-the-spot diagnostics. In this report, we conduct an in-depth review of FDA-approved portable ultrasound devices suitable for professional field use. We focus on models compatible with mobile devices (iOS and Android) and highlight options available at a minimal budget. Portable ultrasound scanners have become invaluable in emergency medicine, remote healthcare, and battlefield or disaster settings where traditional cart-based machines are impractical. This review will compare top portable ultrasound devices in terms of features, compatibility, FDA clearance, and cost, to help guide clinicians and organizations in selecting the right device.
Introduction to Portable Ultrasound in the Field
Portable ultrasound devices are palm-sized or pocket-sized scanners that connect to a mobile device or have an integrated screen, enabling ultrasound imaging at the point of care. Unlike traditional ultrasound machines that are bulky and expensive, portable ultrasound units are lightweight and relatively affordable, broadening access to ultrasound imaging. Since the late 2010s, advances in technology (such as semiconductor “ultrasound-on-a-chip” probes and wireless transducers) have dramatically improved the availability of portable ultrasound for clinicians in resource-limited settings. FDA approval (typically via the 510(k) clearance process) is crucial for these devices, ensuring they meet safety and efficacy standards for clinical use. All devices reviewed here are FDA-cleared for diagnostic ultrasound applications.
For professional field use – such as emergency medical services, rural clinics, military medicine, and humanitarian missions – key considerations include durability, battery life, imaging quality, and ease of use. Many portable scanners are designed with robust, sealed enclosures to withstand drops, extreme temperatures, and rigorous disinfection in the field. Battery-powered wireless probes or phone-tethered devices allow imaging in austere environments where power outlets are scarce. Although handhelds historically had somewhat lower image quality than full-size machines, studies show they can achieve diagnostic accuracy close to cart-based systems for many applications. The convenience and immediacy of a portable ultrasound in hand often outweigh the slight trade-offs in image resolution, especially when immediate decisions are needed in the field.
Leading FDA-Approved Portable Ultrasound Devices
Below we review several leading portable ultrasound devices that are FDA-approved and known for smartphone/tablet compatibility. We emphasize their key features, mobile device integration, FDA clearance status, and approximate pricing. All of these devices have been cleared by the U.S. FDA for diagnostic use and have been adopted in clinical practice.
Butterfly iQ (Butterfly Network)
The Butterfly iQ is a groundbreaking handheld ultrasound that connects to a smartphone (initially iPhone, now both iOS and Android). It was the first ultrasound-on-a-chip device, housing an entire ultrasound array on a semiconductor chip rather than traditional piezoelectric crystals. FDA-cleared in 2017 with one of the broadest ever clearances (approved for 13 clinical applications in a single probe), the Butterfly iQ gained attention for its low cost and versatility. The device provides 3-in-1 functionality, combining the capabilities of linear, convex, and phased array transducers into a single probe. This means a clinician can image superficial structures, deep organs, and perform cardiac scans all with the same unit, simply by changing app presets.
Key Features: The Butterfly iQ offers B-mode, M-mode, and Color Doppler imaging on a HIPAA-compliant mobile app. It also introduced features like cloud storage and telemedicine capabilities (e.g. tele-ultrasound guidance) via subscription services. The probe connects to smartphones/tablets via a cable (USB-C or Lightning), drawing power from the device – a trade-off being unlimited scan time constrained only by the phone’s battery, but a tethered connection (as opposed to wireless). The Butterfly iQ is compatible with iOS and Android platforms; originally it launched on iOS, but Android support soon followed (USB adapters for Android devices and now native USB-C support for newer models).
FDA Approval Status: Cleared by FDA (510(k)) in 2017 for broad use across 13 applications. It was hailed as the first semiconductor-based ultrasound probe with such wide-ranging approval, making high-quality imaging more accessible at the point of care.
Approximate Price: The Butterfly iQ was introduced at $1,999 for the probe. Current models (Butterfly iQ+ and the newer iQ3) are in the range of about $2,699 for the iQ+ (with a 1-year warranty) and $3,899 for the iQ3 (3-year warranty). In addition, Butterfly requires a subscription for cloud and advanced features: the individual plans range from about $299 to $420 per year. Even with the subscription, Butterfly iQ remains one of the most cost-effective portable ultrasound solutions, often cited as “an easy-to-use, powerful, whole-body imaging system that fits in a pocket” at under $2,000.
Philips Lumify
Philips Lumify is a well-established handheld ultrasound platform by Philips Healthcare. Unlike the single-probe Butterfly, Lumify is a family of transducers that plug into a smart device to provide ultrasound imaging. Philips offers a linear transducer (L12-4), a curved abdominal transducer (C5-2), and a phased array transducer (S4-1) under the Lumify brand – users can purchase the probes they need and connect them to a compatible tablet or smartphone. Lumify was cleared by the FDA in 2016 as one of the first app-based ultrasound systems by a major manufacturer.
Key Features: Lumify delivers high-resolution imaging typical of Philips’ larger ultrasound systems, with support for B-mode, Color Doppler, M-mode, and even advanced features like tissue harmonics and Pulse Wave Doppler. The system relies on the user’s device for computing and display; clinicians download the Lumify app (originally Android-only) and connect the transducer via USB. (Philips initially launched Lumify for Android devices, but later introduced an iOS-compatible version with USB-C connectivity – for use with iPads or iPhones that support USB input.) There is no ongoing subscription required to use Lumify; image storage can be managed through hospital PACS or cloud solutions of the user’s choice. Lumify transducers are known for their excellent image quality and reliability, suitable for a broad range of exams from abdominal and lung scans to cardiac imaging.
FDA Approval Status: Cleared via FDA 510(k) in 2016. Philips Lumify is FDA-cleared for diagnostic ultrasound across various applications depending on the probe (e.g., S4-1 is geared to cardiac and abdominal use). Each transducer has its own approved indications, and Philips continuously updates the app and presets within the scope of its clearances.
Approximate Price: Philips Lumify is generally priced higher than single-probe competitors. The transducers are often quoted around $6,000–$7,000 each for purchase. For example, one retail source lists the Lumify S4-1 (phased array) at about $7,000, and the Lumify L12-4 linear at around $6,000. Initially, Philips also offered a subscription model (around $199 per month for institutions) as an alternative to upfront purchase. Today, most customers either buy the probes outright (often ~$6K per probe) or through enterprise packages. While the cost per probe is higher, users get the benefit of Philips’ image quality and do not need to pay any subscription fees for usage.
Clarius HD (Clarius Mobile Health)
Clarius is a line of wireless handheld ultrasound scanners made by Clarius Mobile Health. These scanners connect to a smartphone or tablet via Wi-Fi/Bluetooth, removing the need for cables. Clarius devices are fully self-contained probes – they have an internal battery and communicate wirelessly with the Clarius Ultrasound App (available for iOS and Android). Clarius offers several models optimized for different applications (e.g., C3 convex for general abdominal, L7 linear for vascular/MSK, etc.), and recently introduced a third-generation (HD3) lineup that is 30% lighter and smaller than prior models.
Key Features: Clarius scanners are praised for near hospital-grade imaging in a pocket device. The HD3 series uses traditional piezoelectric transducers (not chip-based) with advanced Octal Beamforming to achieve high frame rates and resolution. The devices are fully sealed and rated for durability – being wireless, they have no ports and are often water-resistant. Clarius probes have swappable batteries; each battery provides up to about 60 minutes of scanning, and you can carry spares to extend usage in the field. Imaging modes include B-mode, Color/Power Doppler, and with a subscription, advanced modes like Pulsed Wave Doppler and specialized presets (e.g., for obstetrics, musculoskeletal, etc.). The app interface relies on AI to simplify use – for example, auto-optimization of gain and depth – making it user-friendly for clinicians less experienced with ultrasound knobs and dials. Clarius supports both Android and iOS devices, giving it broad compatibility.
FDA Approval Status: All Clarius ultrasound scanners are FDA 510(k) cleared for medical use. The newest Clarius HD3 models were cleared by the FDA in the United States (and similarly carry Health Canada approval and CE marking for Europe). Clarius has been in the U.S. market since around 2017, with iterative improvements; each model and software update is released under regulatory compliance.
Approximate Price: Clarius employs a unique pricing model. As of 2022, Clarius announced an “affordable package” starting at $2,995 (USD) for the scanner with an annual membership of $595. This membership unlocks all advanced software features and cloud services. Alternatively, customers can make a one-time purchase of a Clarius scanner starting around $4,900 without a subscription (add-on software packages can be purchased à la carte). In practical terms, a new Clarius HD3 probe can be obtained for roughly $3,000 upfront (with ongoing $595/year) – roughly a fraction of the cost of a traditional ultrasound machine. For example, Clarius lists its popular Convex C3 HD3 and Linear L7 HD3 models at around $3,595 on their store (plus the membership). This makes Clarius a mid-range option: more expensive than the Butterfly iQ, but still quite accessible given its high imaging quality and the fact that no separate display device is needed beyond your smartphone or tablet.
GE Vscan Air
GE Healthcare’s Vscan Air is the latest in the Vscan family, which has a legacy dating back to one of the first pocket ultrasounds over a decade ago. The Vscan Air, introduced in 2021, is a wireless handheld ultrasound probe with dual transducers in one device. One side of the probe houses a high-frequency linear array for shallow scanning, and the other side a lower-frequency curved (or phased) array for deep imaging – allowing whole-body scanning by simply flipping the probe. GE offers two variants: Vscan Air CL (Curved + Linear) and Vscan Air SL (Sector Phased + Linear), catering to general use and cardiac-focused use respectively.
Key Features: The Vscan Air is completely wireless and notably lightweight – it is one of the lightest handhelds on the market. It connects via Bluetooth/Wi-Fi to the Vscan mobile app (available for Android and iOS) on the user’s device. GE has engineered the probe to be rugged: it meets military-grade durability standards (withstanding drops, water immersion, and extreme temperatures) for reliable field use. The Vscan Air supports B-mode, M-mode, Color Doppler, and even Pulsed Wave Doppler for vascular and cardiac assessments. A unique aspect is that GE does not require any subscription for basic functionality – the device can store images locally and transfer via DICOM securely without mandatory cloud fees. However, GE offers optional subscription add-ons (e.g., for additional AI tools and telemedicine features): for instance, a package including MyRemoteShare (live scan sharing) and AI auto-ejection fraction was noted with an extra cost. Battery life is around 50 minutes of active scanning on a full charge, and the probe recharges relatively quickly (and can quick-charge between exams).
FDA Approval Status: The Vscan Air received FDA 510(k) clearance in 2021 for the initial CL model (K202035) and later in 2023 for the SL model (K231301) as GE expanded its indications. Both models are FDA-cleared for whole-body ultrasound imaging (with the exact indications aligning with their transducer capabilities – e.g., cardiac imaging on the SL). GE’s long history in ultrasound meant the Vscan Air was developed to meet clinical standards, and it has been validated in studies by independent experts (who rated it highly for image quality in certain views, such as abdominal and cardiac exams).
Approximate Price: The GE Vscan Air is positioned in the mid-to-high price tier of portable ultrasounds. Its price is approximately $4,000 to $5,000 for the base unit, depending on the configuration and any promotions. Market data suggests an average price around $6,000, but some listings have it in the $3,900 – $7,900 range (USD). One source cites a base price of roughly $5,499 for the Vscan Air SL, with optional subscriptions for advanced software (1-year or 3-year packages costing a few hundred dollars extra). In a clinical forum, some users noted the Vscan Air’s image quality was excellent but questioned if it justified the cost difference over cheaper devices like the Butterfly. Nonetheless, the Vscan Air’s dual-probe convenience and GE’s imaging pedigree make it a strong contender for professionals who need reliability in the field.
Mindray TE Air
The Mindray TE Air is a newcomer in the handheld ultrasound market (launched around 2023) from Mindray, a global medical device manufacturer known for more affordable yet high-quality imaging equipment. The TE Air is unique in that it can serve as a 2-in-1 system: it can connect to mobile devices via an app or plug into Mindray’s own cart-based machines (specifically the Mindray TE X ultrasound system) for hybrid use. Currently, the TE Air probe is a phased array transducer designed primarily for deep imaging (cardiac, abdominal) – Mindray focuses on delivering top image quality for these applications with this probe.
Key Features: The TE Air is a wireless probe (with internal battery) that connects to a tablet or phone, but interestingly it also supports wired mode to interface with Mindray’s larger ultrasound consoles as a satellite probe. This 2-in-1 connectivity is touted as a first in the industry. The device offers B-mode, Color Doppler, M-mode, Pulsed Wave Doppler, and even Tissue Doppler Imaging (TDI) for cardiac functionality – a range of modes comparable to larger machines. Experts have noted the image quality is very good (Mindray uses traditional piezoelectric tech, not chip ultrasound). However, a current limitation is that the TE Air is phased-array only (no built-in linear transducer). This means it excels at deep scans (e.g., echocardiography, abdominal FAST exams), but is less optimal for shallow scans like vascular access or soft-tissue MSK exams. Mindray has made the TE Air iOS-compatible only at launch (works with iPhones/iPads), and does not yet support Android. The device does not require a subscription; it saves images to the connected device or can transfer to PACS. Notably, the TE Air lacks cloud storage integration – it relies on internal storage and user-managed transfer, which might be a consideration for some users. Battery life is reported to be over one hour of scanning per charge, and the probe is lightweight and fully wireless for portability.
FDA Approval Status: The Mindray TE Air has FDA 510(k) clearance for diagnostic use in the U.S. (Mindray obtained clearance K231685 in 2023 for the TE Air system). It is also CE marked in Europe. Being FDA-cleared, it meets U.S. standards for safety and performance in ultrasound imaging, allowing it to be marketed for point-of-care use. Mindray’s entry into the U.S. handheld market signals increased competition, which can drive prices down while pushing technology forward.
Approximate Price: Mindray has positioned the TE Air to be competitively priced, typically a bit more affordable than some established Western brands. Reports indicate a price of roughly $4,000–$5,500 for the TE Air probe. One source lists the price around $4,000 for the unit, while another notes about $5,500 as a ballpark with no recurring fees. The exact price may depend on region and negotiation (Mindray often sells via distributors with some flexibility). Even at the higher end (~$5k), it is comparable to GE’s Vscan Air and still less than a multi-probe Lumify setup. With its strong image performance, the TE Air can be a cost-effective choice for clinicians prioritizing cardiac and abdominal imaging in the field – though buyers should note the limited compatibility (iOS only) and the single probe type when considering their specific use cases.
Other Notable Portable Ultrasound Devices
In addition to the devices above, there are other FDA-approved portable ultrasound scanners worth mentioning:
- Healcerion Sonon – The Sonon 300 series (300C convex and 300L linear) from Healcerion was one of the early wireless phone-based ultrasounds. FDA approved in 2018, the Sonon probes stream ultrasound to a smartphone app (iOS or Android) over Wi-Fi. They offer basic imaging modes and have a remarkable battery life (up to 3 hours continuous scanning) which can be advantageous in the field. Sonon devices were marketed as affordable handhelds “at less than 1/10 the cost of a traditional machine”. In practice, their price hovers around $4,000-$6,000 depending on the model and vendor. While not as high-profile as Butterfly or Clarius, Sonon has found use in primary care and remote settings for basic scans. Newer models like Sonon 500L have improved image quality, although the ecosystem and support are more limited due to the company’s smaller footprint.
- Exo (Exo Iris) – A newcomer, Exo is a Silicon Valley-based company developing a handheld ultrasound similar in concept to Butterfly (using advanced chip transducers). The Exo Iris is a 3-in-1 probe (linear, curvilinear, phased) that as of 2024 has obtained FDA clearance and is starting limited release. It is wired (tethered) and currently iOS-only. Exo’s platform touts features like a large 1TB cloud storage and AI integration. While not widely available yet, it represents the next wave of portable ultrasound innovation. Pricing for Exo has not been fully public, but it is expected to be in a similar range to high-end handhelds. Early indications suggest it could be competitive with Butterfly for versatility, though it may carry a higher cost given its enterprise focus.
- Others: There have been portable units like the GE Vscan (original) with a dedicated screen, or the Fujifilm Sonosite iViz, but these are largely discontinued or superseded by the above options. Another device, EchoNous Kosmos, is a high-end hand-carried ultrasound that includes advanced features (even continuous wave Doppler and integrated ECG). However, Kosmos is closer to a ultraportable tablet-based system and comes at a premium price (~$9,000 for probe+tablet) – likely beyond the “minimal budget” category.
Each of these portable ultrasound options has its niche. For example, if cost is the overriding factor, Butterfly iQ or a used Sonon might be the top pick. If highest image quality is needed and budget allows, one might consider Lumify or Kosmos. For a balance of good imaging with no wires, Clarius or Vscan Air are attractive, while Mindray’s TE Air and the upcoming Exo cater to those wanting cutting-edge performance in specific areas like cardiac imaging.
Comparison Table: Top Portable Ultrasound Devices
To summarize the key differences, the table below compares the top portable ultrasound devices discussed (smartphone/tablet compatible models, FDA-cleared). It highlights their brand/model, key features, mobile compatibility, FDA approval status, and approximate price range:
| Brand / Model | Key Features | Smartphone/Tablet Compatibility | FDA Approval | Approx. Price (USD) |
|---|---|---|---|---|
| Butterfly iQ / iQ+ | Single-probe 3-in-1 (linear, convex, phased);Ultrasound-on-chip tech; cloud storage & telemedicine features via app; B/M/Color Doppler modes. | iOS and Android (wired: Lightning or USB-C) | Yes – 510(k) cleared 2017 (broad 13 applications) | ~$2,000 (probe only); $2,699 for iQ+ (+$299–$420/yr subscription) |
| Philips Lumify | Multiple probe options (linear, curved, phased) for high-quality imaging;Advanced imaging modes (Color, PW Doppler, etc.); no subscription required; uses device for storage/PACS integration. | Android (native app) and iOS (with USB-C adapter/app) | Yes – 510(k) cleared 2016 (probes cleared for POCUS use) | ~$6,000–$7,000 per probe (purchase outright; subscription model $199/mo was optional) |
| Clarius HD3 | Wireless handheld (swappable battery);Multiple models (specialized transducers); AI auto-optimization; app with optional advanced features (via membership); sealed, waterproof design. | iOS and Android (wireless app connectivity) | Yes – FDA cleared (latest HD3 in 2022) | ~$3,000 + $595/yr (membership); or ~$4,900 one-time (3-year warranty included) |
| GE Vscan Air | Dual-headed wireless probe (two-in-one: linear + curved or phased);High-quality imaging with GE SignalMax tech; no base subscription needed; rugged (drop-resistant, IP67); quick charging. | iOS and Android (wireless app; Note: initial release CL model optimized for iOS) | Yes – FDA 510(k) cleared 2021 (CL) and 2023 (SL) | ~$4,000 – $6,000 (avg. ~$5k); Optional AI/telemed subscription add-ons ($400+ extra) |
| Mindray TE Air | Wireless phased-array probe (deep imaging focus);High image quality (piezoelectric); supports PW Doppler & TDI; unique wired pairing with Mindray cart systems; no subscription or cloud (local storage). | iOS only (iPhone/iPad app) (no Android support as of 2024) | Yes – FDA 510(k) cleared 2023 | ~$4,000 – $5,500 (no recurring fees) |
| Healcerion Sonon | Wireless handheld (Wi-Fi to phone);Models: 300C (convex), 300L/500L (linear); basic imaging for primary care; long battery life (~3 hours); supports DICOM/PACS. | iOS and Android (mobile app on App Store/Google Play) | Yes – FDA approved 2018 | ~$4,000 – $6,000 (varies by model) |
Table: Comparison of FDA-approved portable ultrasound devices compatible with smartphones/tablets, including key features, platform compatibility, approval status, and price. Note: Prices are approximate and can vary; lower prices may reflect base hardware only (subscriptions or software packages extra). FDA clearance ensures each device can be legally marketed for medical use in the U.S., but specific approved indications may differ by device (e.g., certain probes optimized for specific exams).
External Authoritative Links (Resources for Further Information)
For more detailed information and official resources on portable ultrasound devices, please refer to the following external links:
- FDA 510(k) Database – Diagnostic Ultrasound: Search the FDA’s database for 510(k) clearances of portable ultrasound devices (e.g., Butterfly iQ, Philips Lumify) to see regulatory details and indications.
- Butterfly Network – Official Butterfly iQ Product Page: Manufacturer’s site with specifications, pricing, and clinical resources for the Butterfly iQ handheld ultrasound.
- Philips Lumify Official Site: Philips Healthcare’s page for Lumify, including device compatibility list, probe details, and user guides.
- Clarius Mobile Health – Handheld Ultrasound Scanners: Official Clarius website with product lineup (HD3 scanners), pricing options, and demo videos of wireless scanners in use.
- GE Healthcare Vscan Family: GE’s information page on Vscan Air (and other Vscan devices), including technical specs and clinical application notes for the dual-headed probe.
- Mindray TE Air – Product Brochure: Mindray’s page or PDF brochure detailing the TE Air’s features, connectivity, and use cases, as well as any updates on Android support.
- Clinical Review – Point-of-Care Ultrasound Devices (2024): The Ultrasound Journal comparative study of handheld ultrasound devices, providing expert evaluations of image quality and ease-of-use for devices like Butterfly, Lumify, Vscan Air, etc.
- ACEP Emergency Ultrasound Section – Handheld Ultrasound Round-up (2024): An overview by the American College of Emergency Physicians reviewing the latest in handheld ultrasounds for EM clinicians, including pros/cons of each device and practical field considerations.
By consulting these resources, readers can obtain the most current and authoritative information on portable ultrasound devices, FDA approvals, and real-world evaluations. The landscape of portable ultrasound technology is continually advancing, with new models and software enhancements emerging. These devices are empowering healthcare providers to bring imaging to the patient’s side – whether in a rural village, an ambulance, or a forward operating base – thus improving diagnostic capabilities in the field like never before.
Internal Link
Top 10 Portable Ultrasound Machines for On-the-Go Scanning in 2025
External Links
Butterfly Network – Official Butterfly iQ Product Page
Provides comprehensive information on the Butterfly iQ portable ultrasound device, including specifications, applications, and purchasing options.
https://www.butterflynetwork.com/Philips Lumify – Handheld Ultrasound Solutions
Details the features, compatibility, and clinical applications of the Philips Lumify handheld ultrasound devices.
https://www.usa.philips.com/Clarius Mobile Health – Portable Handheld Ultrasound Systems
Offers insights into Clarius’s range of wireless handheld ultrasound scanners, highlighting their AI capabilities and suitability for various medical specialties.
https://clarius.com/GE Healthcare – Vscan Air™ Handheld Ultrasound
Provides detailed information on the Vscan Air™ wireless handheld ultrasound device, including its dual-probe technology and clinical applications.
https://www.gehealthcare.com/
