Skip to content

FDXConsole DR-ID300CL

by Fujifilm Corporation

Ref 04547410316865

FDXConsole DR-ID300CL 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 454741010100000000000313B), cleared under FDA 510(k) K170451 on 16 Mar 2017 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04547410316865), 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) K170451

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 Number454741010100000000000313B Basic UDI-DI 04547410316865UDI-DIDate21 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170451 Date16 Mar 2017DecidedStatusActive
United StatesGUDID listing GUDID Number04547410316865 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741010100000000000313B registered 21 May 2026 Active
  • FDA 510(k) K170451 decided 16 Mar 2017 Active
  • FDA GUDID UDI-DI 04547410316865 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 04547410316865
  2. Cleared FDA 510(k) K170451
  3. Registered EUDAMED 454741010100000000000313B

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  • Withdrawn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
Console Advance EUDAMED
FDXConsole GUDID
Generic name
Computed radiography digital imaging scanner
Device name
Dr-Id 300CL
Model / reference
04547410316865 EUDAMED
DR-ID300CL GUDID
Primary DI / UDI-DI
04547410316865
Basic UDI-DI
454741010100000000000313B
510(k) Number
FDA product code
LLZ
EMDN code
Z11069005 Diagnostic imaging workstations
GMDN term
Computed radiography digital imaging scanner
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
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
04547410316865
GUDID
DR-ID300CL
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: Computed radiography digital imaging scanner

Similar devices in this category

Other devices filed under DIAGNOSTIC IMAGING WORKSTATIONS.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

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