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Varex Imaging ICX251B

by Varex Imaging Corporation

Ref 165575Model ICX251B

Varex Imaging ICX251B is an ionization chamber radiation measuring probe (EU MDD Class IIb; FDA Class I; FDA product code IZO, Generator, High-Voltage, X-Ray, Diagnostic) made by Varex Imaging Corporation, registered in EUDAMED on 13 May 2026 (Basic UDI-DI B-08718755002485) and listed in FDA GUDID since 4 Mar 2022 (UDI-DI 08718755002485), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08718755002485 Basic UDI-DI 08718755002485UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08718755002485 UDI-DI Date4 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08718755002485 registered 13 May 2026 Active
  • FDA GUDID UDI-DI 08718755002485 listed 4 Mar 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08718755002485
  2. Registered EUDAMED B-08718755002485

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Varex Imaging
Generic name
Ionization chamber radiation measuring probe
Device name
Ionization Chamber series MDD
Model / reference
ICX251B, 165575
Primary DI / UDI-DI
08718755002485
Basic UDI-DI
B-08718755002485
FDA product code
IZO
EMDN code
Z11030599 Radiology instruments - other
GMDN term
Ionization chamber radiation measuring probe
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
892.1700
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb 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: Ionization chamber radiation measuring probe

Similar devices in this category

Other devices filed under RADIOLOGY INSTRUMENTS - OTHER.

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Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)