GE PHOTON ENERGY RECOVERY (PER) OPTION


Device Classification Name

system, tomography, computed, emission

510(k) Number K023932
Device Name GE PHOTON ENERGY RECOVERY (PER) OPTION
Original Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
4 hayozma st., p.o. box 170
tirat hacarmel, 

IL

30200

Original Contact hemy neuman
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 11/26/2002
Decision Date 12/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No