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Medis 55MP1H Single-Head Medical Diagnostic Display System

by Barco NV Display Systems

510(k) K001752

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 NumberK001752 Date19 Jul 2000ClearedStatusActive

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  • Withdrawn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, 19 Sep 2026

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

The Medis 55MP1H Single-Head Medical Diagnostic Display System is a medical diagnostic display device designed for the review and digital processing of medical images. It falls under the category of a single-head display system, intended for use by trained practitioners in radiology for disease detection, diagnosis, or patient management.

This system is supplied as a reusable medical device and is intended for use in radiology settings. It has received FDA 510(k) clearance under K-number K001752, classified as substantially equivalent to a predicate device. The device is regulated under the Radiology advisory committee and is not indicated for MRI use or single-use applications.

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