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Magnification table MAG TABLE HA E

by Fujifilm Corporation

Ref 04547410241914

Magnification table MAG TABLE HA E is a device classified as Class I in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 4547410101000000000008644), cleared under FDA 510(k) K133972 on 25 Mar 2014 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04547410241914), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133972

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 Number4547410101000000000008644 Basic UDI-DI 04547410241914UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410241914 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK133972 Date25 Mar 2014IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4547410101000000000008644 registered 27 May 2026 Active
  • FDA 510(k) K133972 decided 25 Mar 2014 Active
  • FDA GUDID UDI-DI 04547410241914 listed 16 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0661-2018 FDA Class II initiated 4 Aug 2017

    FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The acquisition workstations, FDR1000AWS, FDR-2000AWS, FDR-3000AWS, and CRIR363AWS assign a unique ID number to every image study but very rarely, with the acquisition workstation software versions, VS.O, VS.1, VS.2 , V6.0, V6.1, and V7.0, the system may assign the same ID number to a new set of images that was already assigned to the previous set of images due to the error in ID number generation logic. If an Image with this error (with duplicate ID number) Is transmitted to PACS, it may overwrite the image already stored on PACS.

    • Terminated Z-0386-2018 FDA Class II initiated 14 Jul 2017

    There was a case that the swivel arm went down unintentionally when it was moved up/down.

Timeline

5 dated events

  1. Cleared FDA 510(k) K133972
  2. Listed FDA GUDID 04547410241914
  3. Recall initiated FDA recalls Z-0386-2018
  4. Recall initiated FDA recalls Z-0661-2018
  5. Registered EUDAMED 4547410101000000000008644

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
898Y101487 EUDAMED
Magnification table GUDID
Generic name
Stationary mammographic x-ray system, digital
Model / reference
04547410241914 EUDAMED
MAG TABLE HA E GUDID
Primary DI / UDI-DI
04547410241914
Basic UDI-DI
4547410101000000000008644
510(k) Number
FDA product code
MUE
EMDN code
Z1103028099 Mammography systems - hardware - other
GMDN term
Stationary mammographic x-ray system, digital
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1715
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
04547410241914
GUDID
MAG TABLE HA E
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Stationary mammographic x-ray system, digital

Cleared under the same submission (K133972)

and 8 more cleared under K133972

Similar devices in this category

Other devices filed under MAMMOGRAPHY SYSTEMS.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)