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FDR SE Console DR-ID330CL

by Fujifilm Corporation

Ref 04547410414530

FDR SE Console DR-ID330CL is a device classified as Class IIa in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 454741010100000000000533M), cleared under FDA 510(k) K192440 on 1 Nov 2019 and listed in FDA GUDID since 13 Dec 2019 (UDI-DI 04547410414530), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K192440

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741010100000000000533M Basic UDI-DI 04547410414530UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410414530 UDI-DI Date13 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK192440 Date1 Nov 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741010100000000000533M registered 21 May 2026 Active
  • FDA 510(k) K192440 decided 1 Nov 2019 Active
  • FDA GUDID UDI-DI 04547410414530 listed 13 Dec 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K192440
  2. Listed FDA GUDID 04547410414530
  3. Registered EUDAMED 454741010100000000000533M

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
FDR SE Console
Generic name
Diagnostic x-ray digital imaging conversion system
Device name
Dr-Id 330CL
Model / reference
04547410414530 EUDAMED
DR-ID330CL GUDID
Primary DI / UDI-DI
04547410414530
Basic UDI-DI
454741010100000000000533M
510(k) Number
FDA product code
MQB
EMDN code
Z11069005 Diagnostic imaging workstations
GMDN term
Diagnostic x-ray digital imaging conversion system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1680
Special device type
Software
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04547410414530
GUDID
DR-ID330CL
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Diagnostic x-ray digital imaging conversion system

Similar devices in this category

Other devices filed under DIAGNOSTIC IMAGING WORKSTATIONS.

Other devices from Fujifilm Corporation

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Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)