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Fdr Cross Dr-Xd 3000

by Fujifilm Corporation

Ref 04547410467710

Fdr Cross Dr-Xd 3000 is a device classified as Class IIb in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 454741010100000000001313G), cleared under FDA 510(k) K212956 on 8 Nov 2021 and listed in FDA GUDID since 28 Dec 2021 (UDI-DI 04547410467710), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212956

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741010100000000001313G Basic UDI-DI 04547410467710UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410467710 UDI-DI Date28 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212956 Date8 Nov 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741010100000000001313G registered 2 Jul 2026 Active
  • FDA 510(k) K212956 decided 8 Nov 2021 Active
  • FDA GUDID UDI-DI 04547410467710 listed 28 Dec 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212956
  2. Listed FDA GUDID 04547410467710
  3. Registered EUDAMED 454741010100000000001313G

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  • Withdrawn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 Cross
Generic name
Mobile general-purpose fluoroscopic x-ray system, digital
Model / reference
04547410467710 EUDAMED
DR-XD 3000 GUDID
Primary DI / UDI-DI
04547410467710
Basic UDI-DI
454741010100000000001313G
510(k) Number
FDA product code
OWB, JAA
EMDN code
Z11039017 Mobile radioscopic units
GMDN term
Mobile general-purpose fluoroscopic x-ray system, digital
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650
System or procedure pack
System which is a device in itself
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
04547410467710
GUDID
DR-XD 3000
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Mobile general-purpose fluoroscopic x-ray system, digital

Cleared under the same submission (K212956)

and 5 more cleared under K212956

Similar devices in this category

Other devices filed under MOBILE RADIOSCOPIC UNITS.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)