• 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, Tomography, Computed, Emission
510(k) Number K022960
Device Name GE QUASAR NUCLEAR MEDICINE SYSTEM
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
10 HAYOZMA ST.
TIRAT HACARMEL,  IL 30200
Applicant Contact HEMY NEUMAN
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact HEINZ JOERG STENEBERG
Regulation Number892.1200
Classification Product Code
KPS  
Date Received09/06/2002
Decision Date 09/19/2002
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
-
-