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Bladder AI (AIBV01)

by Exo, Inc. 510(k)

Active United States

510(k) K230497

Overview

Bladder AI (AIBV01) is a standalone software medical device that assists healthcare providers in assessing bladder ultrasound images. It accepts DICOM-formatted ultrasound images as input and utilizes machine-learning-based semi-automatic landmark placement to identify bladder borders, enabling the calculation of bladder volume.

The device is supplied as software and is intended for use in radiology settings. It is a Class 2 device cleared through the Traditional 510(k) pathway by the FDA with authorization number K230497. The device is not described as single-use or reusable, and no specific MRI safety information is provided.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230497 Date22 Jun 2023ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Exo, Inc.

Questions

  • What is Bladder AI (AIBV01) used for?

    Bladder AI (AIBV01) is a standalone software medical device designed to assist healthcare providers in assessing bladder ultrasound images. It uses machine learning to identify bladder borders and calculate bladder volume from DICOM-formatted ultrasound images.

  • How is Bladder AI (AIBV01) supplied?

    Bladder AI (AIBV01) is supplied as software intended for use in radiology settings. It accepts DICOM-formatted ultrasound images as input and processes them to provide bladder volume calculations.

  • What is the regulatory status of Bladder AI (AIBV01)?

    Bladder AI (AIBV01) is a Class 2 device cleared through the Traditional 510(k) pathway by the FDA with authorization number K230497. It was found to be substantially equivalent to existing devices.

  • Is Bladder AI (AIBV01) single-use or reusable?

    The device is not described as single-use or reusable in the provided information. As a software medical device, its usage would depend on the software licensing terms and the healthcare provider's implementation policies.