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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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
De Novo Number DEN180005
Device Name OsteoDetect
Requester
Imagen Technologies, Inc.
33 east 33rd street, suite 506
new york,  NY  10016
Contact alex dresner
Regulation Number892.2090
Classification Product Code
QBS  
Date Received02/05/2018
Decision Date 05/24/2018
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-