• 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 interventional fluoroscopic x-ray system
510(k) Number K936180
Device Name TC+ SYSTEM (TILTING C-ARM SYSTEM)
Original Applicant
GE MEDICAL SYSTEMS
3000 n grandview blvd.
w-709
waukesha,  WI  53188
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received12/27/1993
Decision Date 03/16/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-