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Vitrea Advanced Visualization 7.16.4.SU01

by Canon Medical Informatics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850025268400 UDI-DI Date27 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Vitrea Advanced Visualization
Generic Name
Radiological PACS-dedicated management software
Model / Reference
7.16.4.SU01
Primary DI / UDI-DI
00850025268400
FDA Product Code
LLZ, JAK, LMD
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class II
Regulation Number
892.2050, 892.1750, 892.2020
GUDID distribution status
In Commercial Distribution

Other devices from Canon Medical Informatics, Inc.

See all devices from Canon Medical Informatics, Inc. →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No