Clarius Ultrasound Scanner
K192107Clarius Mobile Health Corp. · cleared 2019-08-29 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: ophthalmic, fetal, abdominal, intra-operative (non-neurological), pediatric, small organ, cephalic (adult), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, gynecology, cardiac (adult, pediatric), peripheral vessel, carotid, and procedural guidance of needles into the body. The system is a transportable ultrasound system intended for use in environments where healthcare is provided by trained healthcare professionals.”
Validation studies (1)
Bench
sample size not stated
standards: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-12 Edition 1.0 2014-06, IEC 60601-1-2 Edition 4.0 2014-02, IEC 60601-1-6 Edition 3.1 2013-10, IEC 60601-2-37 Edition 2.1 2015, IEC 62133 Edition 2.0 2012-12, IEC 62304:2006, ISO 10993-10 Third Edition 2010-08-01, ISO 10993-11 Third Edition 2017-09, ISO 10993-5 Third Edition 2009-06-01, ISO 14971 Second Edition 2007-03-01, ISO 15223-1:2012, UD 2-2004 (R2009)
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233955 (decision 2024-06-14) from Clarius Mobile Health Corp. for a matching device line ("Clarius OB AI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233955
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232704 (decision 2023-10-05) from Clarius Mobile Health Corp. for a matching device line ("Clarius Ultrasound Scanner") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232704
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K222406 (decision 2023-01-23) from Clarius Mobile Health Corp. for a matching device line ("Clarius AI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K222406
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K213436 (decision 2021-11-15) from Clarius Mobile Health Corp. for a matching device line ("Clarius Ultrasound Scanner") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K213436
- 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, 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 is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97726
- …and 2 more.
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).