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Fuji Imaging Plate Ip Hr-Bd 18x24cm 2 E

by Fujifilm Corporation

Ref 04547410059427

Fuji Imaging Plate Ip Hr-Bd 18x24cm 2 E (47410-05942) is a device classified as Class IIa in the EU and Class I in the US made by Fujifilm Corporation, registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI 454741010100000000000163F), cleared under FDA 510(k) K862414 on 26 Feb 1987 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04547410059427), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K862414

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741010100000000000163F Basic UDI-DI 04547410059427UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410059427 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK862414 Date26 Feb 1987DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741010100000000000163F registered 11 Jun 2026 Active
  • FDA 510(k) K862414 decided 26 Feb 1987 Active
  • FDA GUDID UDI-DI 04547410059427 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K862414
  2. Listed FDA GUDID 04547410059427
  3. Registered EUDAMED 454741010100000000000163F

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  • Withdrawn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
Fuji Imaging Plate Hr-Bd EUDAMED
Fuji Imaging Plate GUDID
Generic name
Computed radiography digital imaging scanner
Model / Ref / Catalog
04547410059427 EUDAMED
IP HR-BD 18X24CM 2 E GUDID
47410-05942 GUDID
Primary DI / UDI-DI
04547410059427
Basic UDI-DI
454741010100000000000163F
510(k) Number
FDA product code
EAM
EMDN code
Z11060285 Digital computed radiography (cr) systems - consumables
GMDN term
Computed radiography digital imaging scanner
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
892.1960
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
04547410059427
GUDID
IP HR-BD 18X24CM 2 E
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.

Related devices

Category: Computed radiography digital imaging scanner

Cleared under the same submission (K862414)

and 8 more cleared under K862414

Similar devices in this category

Other devices filed under DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)