Identifiers
- 510(k) Number
- K232257 FDA 510(k)
- FDA Product Code
- QIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the primary function of the Clarius Bladder AI?
The Clarius Bladder AI is designed to perform noninvasive, automatic measurements of bladder volume. By identifying and highlighting the bladder, it provides clinicians with data to assist in clinical decision-making and patient interventions.
In which clinical settings can this device be used?
This device is intended for use in professional healthcare environments, including hospitals, clinics, and nursing homes, where assessment of bladder volume is required for patient care.
Has the Clarius Bladder AI received regulatory authorization?
Yes, the Clarius Bladder AI has received 510(k) clearance from the U.S. FDA, as indicated by the submission number K232257.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bladder AI - Automated Bladder Volume Calculation | Clarius, Clarius Bladder AI, PDF Clarius Mobile Health Corp. - Food and Drug Administration, Clarius Bladder AI Review: Pricing, FDA Status & Alternatives ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232257 | Class II | Active |
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Manufacturer
- Manufacturer
- Clarius Mobile Health Corp.
Sources (1)
- FDA 510(k) K232257 24 fields · synced Sep 26, 2026