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Viz LVO 1.3

by Viz.ai

Viz LVO 1.3 is a Class II device made by Viz.ai, granted FDA De Novo DEN170073 on 13 Feb 2018 and listed in FDA GUDID since 22 Mar 2019 (UDI-DI 00811852030042), active (FDA De Novo), not in commercial distribution (GUDID) as of 22 Oct 2026.

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

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

De Novo DEN170073

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811852030042 UDI-DI Date22 Mar 2019ListedStatusListed GUDID: not in commercial distribution
United StatesFDA De NovoDENG from GUDID De Novo granted · Direct NumberDEN170073 Date13 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA De Novo DEN170073 decided 13 Feb 2018 Active
  • FDA GUDID UDI-DI 00811852030042 listed 22 Mar 2019 Listed

Timeline

2 dated events

  1. Granted FDA De Novo DEN170073
  2. Listed FDA GUDID 00811852030042

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

GUDID

Trade name
Viz LVO
Generic name
Radiology DICOM image processing application software
Model / reference
1.3
Primary DI / UDI-DI
00811852030042
De Novo Number
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)