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 Analyzer, Medical Image
510(k) Number K213353
Device Name Aorta-CAD
Applicant
Imagen Technologies, Inc
151 West 26th Street, Suite 1001
New York,  NY  10001
Applicant Contact Robert Lindsey
Correspondent
Imagen Technologies, Inc
151 West 26th Street, 10th Floor
New York,  NY  10001
Correspondent Contact Robert Lindsey
Regulation Number892.2070
Classification Product Code
MYN  
Date Received10/08/2021
Decision Date 09/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-