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Barco MWD 321 Medical Workstation Display

by Barco NV Display Systems

510(k) K972701

Active European Union and United States

CE MDR CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K972701↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK972701 Date2 Jan 1998ClearedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LMD
Device Class
Class I
Regulation
21 CFR Part 892.2020
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Barco MWD 321 Medical Workstation Display is a diagnostic imaging display system designed for use in radiology environments. It provides high-resolution visual output for medical professionals to interpret and analyze radiographic images, ensuring accurate diagnostic assessments.

This display is intended for integration into medical workstations, supplied as a standalone unit with no indication of sterility requirements. It is regulated under FDA 510(k) clearance, IVDR, and MDR compliance, with a product code classification of LMD. The device is non-reusable and intended for use in controlled clinical settings, adhering to manufacturer specifications for display performance and safety.

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