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Faxitron Core 04-4126

by Hologic

Part of a family of 7 devices: see the family page

Ref 04-4126

Faxitron Core 04-4126 is a tissue specimen x-ray system IVD (EU MDR Class I; FDA Class II; FDA product code MWP, Cabinet, x-ray system) made by Hologic, registered in EUDAMED on 15 May 2026 (Basic UDI-DI 54200455FAXITRONCABXRAYBU), cleared under FDA 510(k) K082432 on 21 Nov 2008 and listed in FDA GUDID since 11 Apr 2023 (UDI-DI 25420045516622), 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, self-declared

Class I: no certifier involved

510(k) K082432

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 Number54200455FAXITRONCABXRAYBU Basic UDI-DI 25420045516622UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number25420045516622 UDI-DI Date11 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK082432 Date21 Nov 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 54200455FAXITRONCABXRAYBU registered 15 May 2026 Active
  • FDA 510(k) K082432 decided 21 Nov 2008 Active
  • FDA GUDID UDI-DI 25420045516622 listed 11 Apr 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K082432
  2. Listed FDA GUDID 25420045516622
  3. Registered EUDAMED 54200455FAXITRONCABXRAYBU

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  • Withdrawn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
Faxitron Core Specimen Trays EUDAMED
Faxitron Core GUDID
Generic name
Tissue specimen x-ray system IVD
Device name
Faxitron Radiography System
Model / Ref / Catalog
04-4126
Primary DI / UDI-DI
25420045516622
Basic UDI-DI
54200455FAXITRONCABXRAYBU
Direct marketing DI
25420045516622
510(k) Number
FDA product code
MWP
EMDN code
Z11069005 Diagnostic imaging workstations
GMDN term
Tissue specimen x-ray system IVD
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1680
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Tissue specimen x-ray system IVD

Cleared under the same submission (K082432)

Similar devices in this category

Other devices filed under DIAGNOSTIC IMAGING WORKSTATIONS.

Other devices from Hologic

See all devices from Hologic →

Properties

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