Clarius Ultrasound System

K172385

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

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.3)
“The Clarius Ultrasound Scanner is a software-based ultrasound imaging system and accessories, intended for diagnostic imaging in B-mode, M-mode, Color Doppler, Power Doppler, and Combined (B+M; B+Color Doppler; and B+Power Doppler).”
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

standards: AAMI/ANSI ES60601-1, 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-10993-12, 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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
10
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); 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/K172385