ECAT LSO PET/CT 16


Device Classification Name

system, tomography, computed, emission

510(k) Number K023518
Device Name ECAT LSO PET/CT 16
Original Applicant
CTI PET SYSTEMS, INC.
810 innovation dr.
knoxville, 
TN 
37932 -2571

Original Contact william skremsky
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 10/21/2002
Decision Date 11/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No