• 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 | Inspections
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 K040372
Device Name LIGHTSPEED 7.0 CT SCANNER SYSTEM
Original Applicant
GE MEDICAL SYSTEMS, LLC
3000 n. grandview blvd.
waukesha,  WI  53188
Original Contact john w jaeckle
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/17/2004
Decision Date 03/01/2004
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
Recalls CDRH Recalls
-
-