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 system, x-ray, tomography, computed
510(k) Number K152584
Device Name Stroke VCAR
Applicant
GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE
BUC,  FR 78530
Applicant Contact Peter Uhlir
Correspondent
GE HEALTHCARE
540 W Northwest Highway
Barrington,  IL  60010
Correspondent Contact Jeme Wallace
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/10/2015
Decision Date 01/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-