Skip to content

Faxitron Core Corevision 5X10

by Hologic

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

Ref COREVISION5X10

Faxitron Core Corevision 5X10 (COREVISION5X10) 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 15 Jul 2021 (UDI-DI 15420045514218), 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) 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 15420045514218UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number15420045514218 UDI-DI Date15 Jul 2021ListedStatusListed 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 15420045514218 listed 15 Jul 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K082432
  2. Listed FDA GUDID 15420045514218
  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  • Withdrawn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 Radiography System EUDAMED
Faxitron Core GUDID
Generic name
Tissue specimen x-ray system IVD
Device name
Faxitron Radiography System
Model / Ref / Catalog
COREVISION5X10, COREVISION 5X10
Primary DI / UDI-DI
15420045514218
Basic UDI-DI
54200455FAXITRONCABXRAYBU
Direct marketing DI
15420045514218
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
COREVISION5X10
GUDID
COREVISION 5X10
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

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