Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K253898
Device Name QT Scanner 2000 Model A
Applicant
QT Imaging Holdings, Inc.
3 Hamilton Landing
Suite 160
Novato,  CA  94949
Applicant Contact Bilal Malik
Correspondent
QT Imaging Holdings, Inc.
3 Hamilton Landing
Suite 160
Novato,  CA  94949
Correspondent Contact Bilal Malik
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   QIH  
Date Received12/05/2025
Decision Date 03/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-