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 K040372
Device Name LIGHTSPEED 7.0 CT SCANNER SYSTEM
Applicant
GE MEDICAL SYSTEMS, LLC
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact JOHN W JAECKLE
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
1279 QUARRY LANE, SUITE A
PLEASANTON,  CA  94566
Correspondent Contact JUERGEN WELTE
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/17/2004
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
-
-