Vscan Air

K250087

GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2025-05-01 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices.”

Algorithmdeep learning algorithm to automatically place the measurement calipers in transverse and longitudinal views; Caption AI provides real-time user guidance to assist medical professionals in the acquisition of cardiac ultrasound images and provides an automated estimation of left ventricular ejection fraction.

source quote (p.8)

“Added Auto bladder volume which is a protocol-based measurement tool for calculating urinary bladder volumes. The measurement workflow is similar to Bladder Volume Application cleared in reference device Vscan Extend (K161588), however, Auto bladder volume uses a deep learning algorithm to automatically place the measurement calipers in transverse and longitudinal views when using the Vscan Air CL probe instead of traditional image analysis. Added compatibility with Caption Al which provides real-time user guidance to assist medical professionals in the acquisition of cardiac ultrasound images and provides an automated estimation of left ventricular ejection fraction. Caption Al incorporates two separately cleared software features: Caption Guidance (K201992) and Caption Interpretation AutoEF (K210747).”

Adaptive (vs locked)No

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal safety; electrical safety; electromagnetic safety; mechanical safety

standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 14971, ISO 10993-1, IEC 60601-1-11, IEC 60601-1-12

Retrospective clinical

n=142 patients

endpoints: Bladder volume measurement accuracy; volumetric calculation accuracy; Automatic caliper placement success rate

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97726
recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97843
recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96992
recall_reason_pattern
Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95254

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).