Clarius Ultrasound System

K172385

Clarius Mobile Health Corp. · cleared 2017-09-14 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.10)

“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.”

AlgorithmThe device is a software-controlled diagnostic ultrasound system that acquires and displays high-resolution, real-time ultrasound data.

source quote (p.10)

“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.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (0)

FDA source did not describe a validation study.

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 4 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).