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Contour ProtégéAI 2.0

by Mim Software Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00198953200933 UDI-DI Date17 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Contour ProtégéAI
Generic Name
Radiological PACS-dedicated management software
Model / Reference
2.0
Primary DI / UDI-DI
00198953200933
510(k) Number
FDA Product Code
QKB
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class II
Regulation Number
892.2050
GUDID distribution status
In Commercial Distribution

Other devices from Mim Software Inc.

See all devices from Mim Software Inc. →

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