GE QUASAR NUCLEAR MEDICINE SYSTEM


Device Classification Name

system, tomography, computed, emission

510(k) Number K022960
Device Name GE QUASAR NUCLEAR MEDICINE SYSTEM
Original Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
10 hayozma st.
tirat hacarmel, 

IL

30200

Original Contact hemy neuman
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 09/06/2002
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