LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ

Device Classification Name

system, tomography, computed, emission

510(k) Number K033431
Device Name LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
Applicant
CTI PET SYSTEMS, INC.
810 innovation dr.
knoxville, 
TN 
37932 -2571

Applicant Contact william skremsky
Correspondent
CTI PET SYSTEMS, INC.
810 innovation dr.
knoxville, 
TN 
37932 -2571

Correspodent Contact william skremsky
Regulation Number 892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received 10/28/2003
Decision Date 11/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls