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X-ray App 12-00001

by Treace Medical Concepts, 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 Number00810111225663 UDI-DI Date1 May 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  • Withdrawn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
X-ray App
Generic Name
Radiology DICOM image processing application software
Model / Reference
12-00001
Primary DI / UDI-DI
00810111225663
FDA Product Code
LMD
GMDN Term
Radiology DICOM image processing application software
Device Class
Class I
Regulation Number
892.2020
GUDID distribution status
In Commercial Distribution

Other devices from Treace Medical Concepts, Inc.

See all devices from Treace Medical Concepts, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

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