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 Fracture
510(k) Number K193417
Device Name FractureDetect (FX)
Applicant
Imagen Technologies, Inc.
WeWork, 524 Broadway, 8th Floor
New York,  NY  10012
Applicant Contact Robert Lindsey
Correspondent
Biologics Consulting
1555 King St, Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Classification Product Code
QBS  
Date Received12/09/2019
Decision Date 07/30/2020
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
-
-