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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
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