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 Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K191994
Device Name ProFound AI Software V2.1
Applicant
Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua,  NH  03062
Applicant Contact Heather Reed
Correspondent
Icad, Inc.
98 Spit Brook Rd., Suite 100
Nashua,  NH  03062
Correspondent Contact Heather Reed
Classification Product Code
QDQ  
Date Received07/26/2019
Decision Date 10/04/2019
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
-
-