• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name system, image processing, radiological
510(k) Number K092639
Device Name INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
Original Applicant
GE MEDICAL SYSTEMS SCS
3000 north grandview blvd
w450
waukesha,  WI  53188
Original Contact nicole landreville
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/27/2009
Decision Date 12/02/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-