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Imagepro

by Browne Medical Systems, Inc. 510(k)

Active United States

510(k) K910444

Overview

The Imagepro is a Cystometric Gas (Carbon-Dioxide) On Hydraulic Device, classified as a class 2 device. It is used in the medical specialties of Gastroenterology and Urology. The device is substantially equivalent to other devices on the market.

The Imagepro is supplied by Browne Medical Systems, Inc. and has been assigned the product code FAP and regulation number 876.1620. It has been cleared by the FDA with the k number K910444. The device is intended for use in a clinical setting and is subject to the regulations and guidelines set forth by the FDA.

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 NumberK910444 Date10 Jun 1991ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

Full name
Browne Medical Systems Imagepro
510(k) Number
FDA Product Code
FAP
Device Class
Class II
Regulation
21 CFR Part 876.1620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Browne Medical Systems, Inc.

Questions

  • What is the Imagepro device used for?

    The Imagepro is used in the medical specialties of Gastroenterology and Urology, specifically as a Cystometric Gas (Carbon-Dioxide) On Hydraulic Device.

  • Is the Imagepro device supplied sterile?

    The device data does not specify if the Imagepro is supplied sterile, but it is intended for use in a clinical setting and subject to FDA regulations.

  • What is the regulatory classification of the Imagepro device?

    The Imagepro is classified as a class 2 device, with the product code FAP and regulation number 876.1620, and has been cleared by the FDA with the k number K910444.