GE CT-PET SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K010641
Device Name GE CT-PET SYSTEM
Original Applicant
GE MEDICAL SYSTEMS, INC.
p.o. box 414
milwaukee, 
WI 
53201

Original Contact d duersteler
Regulation Number 892.1750
Classification Product Code
JAK  
Subsequent Product Code
KPS  
Date Received 03/05/2001
Decision Date 03/30/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party Yes

Combination Product

No