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Viz ICH

by Viz.ai

Ref 081185203VIZICHBG

Viz ICH (081185203VIZICHBG) is a device classified as Class IIa in the EU and Class II in the US made by Viz.ai, registered in EUDAMED on 15 Nov 2024 (Basic UDI-DI 081185203VIZICHBG), cleared under FDA 510(k) K210209 on 23 Mar 2021 and listed in FDA GUDID since 6 Apr 2022 (UDI-DI 00811852030318), 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) K210209

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 Number081185203VIZICHBG Basic UDI-DI Date15 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00811852030318 UDI-DI Date6 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK210209 Date23 Mar 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081185203VIZICHBG registered 15 Nov 2024 Active
  • FDA 510(k) K210209 decided 23 Mar 2021 Active
  • FDA GUDID UDI-DI 00811852030318 listed 6 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K210209
  2. Listed FDA GUDID 00811852030318
  3. Registered EUDAMED 081185203VIZICHBG

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  • Withdrawn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

Generic name
Radiology DICOM image processing application software
Model / reference
081185203VIZICHBG EUDAMED
Viz ICH Software GUDID
Primary DI / UDI-DI
00811852030318, 00811852030370
Basic UDI-DI
081185203VIZICHBG
Direct marketing DI
00811852030318
00811852030370
510(k) Number
FDA product code
QAS
EMDN code
Z12109082 Various neurology and neurosurgery instruments - software accessories
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2080
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
081185203VIZICHBG
GUDID
Viz ICH Software
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000024837
Authorised representative
AJW Technology Consulting GmbH DE-AR-000004999

Similar devices in this category

Other devices filed under VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS.

Other devices from Viz.ai

  • Viz ICH

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  • Viz ICH+ Software

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See all devices from Viz.ai →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)