Clarius Bladder AI

K232257

Clarius Mobile Health Corp. · cleared 2023-11-13 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Clarius Bladder AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (AI), utilizing non-adaptive machine learning algorithms”
AlgorithmDeep Neural Network
source quote (p.9)
“Image segmentation for border detection, and bladder view classification using a Deep Neural Network.”
Adaptive (vs locked)No
source quote (p.5)
“Clarius Bladder AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (AI), utilizing non-adaptive machine learning algorithms”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“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)

Retrospective clinical

n=66 patients

endpoints: non-inferiority to manual measurement by expert clinician

Prospective clinical

n=58 patients · 1 site(s)

endpoints: non-inferiority to manual measurement by expert clinician

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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

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/K232257