Clarius Ultrasound Scanner

K180799

Clarius Mobile Health Corp. · cleared 2018-05-14 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesimd

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.”

AlgorithmFDA source did not state this

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: Basic Safety and Essential Performance; Electromagnetic Capability; Usability; Safety Requirements for Portable Sealed Secondary Cells and Batteries; Application of Usability Engineering; Biological evaluation of medical devices (risk management, in vitro cytotoxicity, irritation and skin sensitization, systemic toxicity, sample preparation and reference materials); Software Life Cycle Processes; Symbols to be Used with Medical Devices Labels, Labeling, and Information to be Supplied; Applications of Risk Management; Acoustic Output Measurement

standards: AAMI/ANSI ES60601-1, AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, Mod). (General II (ES/EMC)), IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-12, IEC 60601-2-37, IEC 62133, IEC 62366, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO-10993-12, ISO 62304, ISO 15223-1, ISO 14971, NEMA UD 2

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

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K192107 (decision 2019-08-29) 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:K192107
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
…and 3 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).