Clarius Ultrasound System

K163138

Clarius Mobile Health Corp. · cleared 2016-11-30 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware

source quote (p.8)

“The Clarius Ultrasound System is a portable, general-purpose, software-controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) iOS or Android device.”

AlgorithmFDA source did not state this

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: compliance to the following standards

standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K180799 (decision 2018-05-14) 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:K180799
…and 5 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).