Clarius Ultrasound System

K163138

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

Premarket evidence — what FDA accepted

Device typesimd
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
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
11
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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K163138