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Viz ICH 1.3

by Viz.ai

Viz ICH 1.3 is a Class II device made by Viz.ai, registered in EUDAMED and listed in FDA GUDID since 3 Apr 2020 (UDI-DI 00811852030165), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00811852030165 UDI-DI Date3 Apr 2020ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 00811852030165 listed 3 Apr 2020 Listed

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Viz ICH
Generic name
Radiology DICOM image processing application software
Model / reference
1.3
Primary DI / UDI-DI
00811852030165
FDA product code
QAS
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2080
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code QAS (Radiological computer-assisted triage and notification software).

Other devices from Viz.ai

  • Viz ICH

    Class II
  • Viz CTP

    Class II
  • Viz HCM Software

    Class II
  • Viz ICH+ Software

    Class II

See all devices from Viz.ai →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)