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QT Scanner 2000 Model B

by Qt Imaging, 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 Number00852619008041 UDI-DI Date24 Jun 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  • Withdrawn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
QT Scanner 2000
Generic Name
General-purpose ultrasound imaging system
Model / Ref / Catalog
Model B, 100950
Primary DI / UDI-DI
00852619008041
FDA Product Code
IYO, ITX
GMDN Term
General-purpose ultrasound imaging system
Device Class
Class II
Regulation Number
892.1560, 892.1570
GUDID distribution status
In Commercial Distribution

Other devices from Qt Imaging, Inc.

Properties

  • Serial Number

Other properties (13)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No