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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 K122429
Device Name VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
Applicant
OBJECT RESEARCH SYSTEMS (ORS) INC.
760 st-paul west
suite 101
montreal, 
Contact eric f ournier
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/09/2012
Decision Date 11/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
-
-