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RadiCS Ver.5.3

by Eizo Corporation 2 variants

Ref RDCSALZZV530

RadiCS Ver.5.3 is a device classified as Class IIa in the EU and Class I in the US made by Eizo Corporation, registered in EUDAMED on 30 Jul 2026 (Basic UDI-DI 4995047QASoftware2JP) and listed in FDA GUDID since 4 Sep 2026 (UDI-DI 04995047069485), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04995047069485 UDI-DI Date4 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number4995047QASoftware2JP Basic UDI-DI 04995047069485UDI-DIDate30 Jul 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4995047QASoftware2JP registered 30 Jul 2026 Active
  • FDA GUDID UDI-DI 04995047069485 listed 4 Sep 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 4995047QASoftware2JP
  2. Listed FDA GUDID 04995047069485

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
RadiCS Ver.5.3 EUDAMED
RadiCS GUDID
Generic name
Radiology workstation display quality assurance software
Device name
Monitor Quality Control Software
Model / Ref / Catalog
RDCSALZZV530 EUDAMED
Ver.5.3 GUDID
RadiCS Ver.5.3 GUDID
Primary DI / UDI-DI
04995047069485
Basic UDI-DI
4995047QASoftware2JP
FDA product code
LHO
EMDN code
Z119014 Video recorders for bioimages
GMDN term
Radiology workstation display quality assurance software
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
892.1940
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RDCSALZZV530
GUDID
Ver.5.3
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

Other devices from Eizo Corporation

See all devices from Eizo Corporation →

Properties

  • Prescription use
  • Premarket exempt
Other properties (23, all answered No)