• 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, image processing, radiological
510(k) Number K173420
Device Name Radiomics App v1.0
Applicant
Microsoft Corp.
1 Microsoft Way
redmond,  WA  98052
Applicant Contact ivan tarapov
Correspondent
Biologics Consulting Group, Inc.
1555 King Street, Suite 300
alexandria,  VA  22314
Correspondent Contact donna-bea tillman
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/01/2017
Decision Date 12/27/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-