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Clarius Bladder AI

by Clarius Mobile Health Corp.

510(k) K232257

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232257 Date13 Nov 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QIH
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Clarius Bladder AI is a noninvasive tool designed to automatically measure bladder volume. It identifies and highlights the bladder to deliver calculations that support clinical decision-making and interventions.

This device has received 510(k) clearance from the U.S. FDA. It is intended for use in settings such as hospitals, clinics, and nursing homes to assist in the assessment of bladder volume.

Devices cleared under K232257

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K232257
UDI-DISize and differences
Clarius Ultrasound Scanner App - Android
Clarius Mobile Health Corp
12-01-00004 / App - Android07540205000403 —On the market
Clarius Ultrasound Scanner App - iOS
Clarius Mobile Health Corp
12-01-00003 / App - iOS07540205000397 —On the market

Similar devices

Other devices filed under FDA product code QIH (Automated Radiological Image Processing Software).

Other devices from Clarius Mobile Health Corp.

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