ECAT PET SCANNER


Device Classification Name

system, tomography, computed, emission

510(k) Number K002715
Device Name ECAT PET SCANNER
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 08/31/2000
Decision Date 10/31/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls