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Medimage

by Vepro - Computersysteme GmbH

510(k) K972215

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972215 Date19 Nov 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Medimage is a radiological image processing system designed for use in radiology environments. It functions as a system for the processing of radiological images.

This device is identified under FDA 510(k) clearance K972215. It is classified as a Class II device under the LLZ product code.

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the primary function of the Medimage system?

    Medimage is a specialized radiological image processing system. It is designed to support radiology environments by providing tools for the processing of radiological images.

  • What is the regulatory status of the Medimage system?

    The Medimage system is identified under FDA 510(k) clearance number K972215. It is classified as a Class II device under the LLZ product code, which pertains to radiological image processing systems.

  • Who is the manufacturer of the Medimage system?

    Medimage is manufactured by Vepro-Computersysteme GmbH, located in Pfungstadt, Germany. The company submitted the device for regulatory review, resulting in a determination of substantial equivalence.