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Ai-Cvd V0.3.0

by Heartlung Corporation

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 Number00860016420922 UDI-DI Date4 Sep 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  • Withdrawn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
Ai-Cvd
Generic Name
Radiology DICOM image processing application software
Model / Reference
V0.3.0
Primary DI / UDI-DI
00860016420922
FDA Product Code
QIH, KGI
GMDN Term
Radiology DICOM image processing application software
Device Class
Class II
Regulation Number
892.2050, 892.1170
GUDID distribution status
In Commercial Distribution

Other devices from Heartlung Corporation

  • AutoBMD V2.2.3

    Class II

  • ABMD Software

    Class II

  • AutoChamber

    Class II

  • Ai-Cvd

    Class II

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

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