OPTIMA PET/CT 560


Device Classification Name

system, tomography, computed, emission

510(k) Number K081496
Device Name OPTIMA PET/CT 560
Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, 
WI 
53188

Applicant Contact david duersteler
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 05/29/2008
Decision Date 06/12/2008
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