Clarius AI

K222406

Clarius Mobile Health Corp. · cleared 2023-01-23 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“Clarius AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (AI), including non-adaptive machine learning algorithms, and is incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering in musculoskeletal (MSK) ultrasound imaging applications.”
Algorithmmachine learning-based algorithm Exception U-Net with MobileNetV2 backbone
source quote (p.10)
“Image segmentation, anatomical identification, and measurement utilizing the machine learning-based algorithm Exception U-Net”
Adaptive (vs locked)No
source quote (p.5)
“Clarius AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (AI), including non-adaptive machine learning algorithms, and is incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering in musculoskeletal (MSK) ultrasound imaging applications.”
PCCPNo
Cybersecurity addressedYes
source quote (p.13)
“Clarius conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient.”

Validation studies (2)

Bench

sample size not stated

endpoints: Safety and performance of Clarius AI (MSK) has been evaluated through verification and validation testing in accordance with software specifications and applicable performance standards.

standards: IEC 62304:2006 + A1:2015 - Medical device software - Software life cycle processes, ISO 14971:2019 Medical devices Application of risk management to medical devices, NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set, IEC 62366-1:2015 + A1:2020 Medical devices Part 1: Application of usability engineering to medical devices, ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

Retrospective clinical

n=73 patients

endpoints: determine whether the Clarius AI (MSK model) software measurement output adequately aligned with expert clinicians' manual caliper placement; verify if Clarius AI auto-measurements are non-inferior to manual measurements performed by licensed clinicians

Reported performance (2 observations)

diceas written: “Dice score”0.96
source quote (p.14)
“The reported average Dice score was 96% and the mean IoU was 94% for tendon segmentation.”
iouas written: “mean IoU”0.94
source quote (p.14)
“The reported average Dice score was 96% and the mean IoU was 94% for tendon segmentation.”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
6
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253593 (decision 2026-03-02) from Clarius Mobile Health Corp. for a matching device line ("Clarius Ejection Fraction AI") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.

    first seen 2026-07-08 · k_number:K253593

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250226 (decision 2025-05-08) from Clarius Mobile Health Corp. for a matching device line ("Clarius Median Nerve AI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250226

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243853 (decision 2025-04-16) from Clarius Mobile Health Corp. for a matching device line ("Clarius Prostate AI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243853

  • 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) K232257 (decision 2023-11-13) from Clarius Mobile Health Corp. for a matching device line ("Clarius Bladder AI") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K232257

  • 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

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/K222406