Skip to content

Viz CTP 1.3

by Viz.ai

Viz CTP 1.3 is a Class II device made by Viz.ai, cleared under FDA 510(k) K180161 on 20 Apr 2018, registered in EUDAMED and listed in FDA GUDID since 20 Aug 2019 (UDI-DI 00811852030103), active (FDA 510(k), EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

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

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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180161

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00811852030103 UDI-DI Date20 Aug 2019ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180161 Date20 Apr 2018DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K180161 decided 20 Apr 2018 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 00811852030103 listed 20 Aug 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180161
  2. Listed FDA GUDID 00811852030103

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  • Withdrawn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
Viz CTP
Generic name
Radiology DICOM image processing application software
Model / reference
1.3
Primary DI / UDI-DI
00811852030103
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code LLZ (System, image processing, radiological).

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)