ECAT ACCEL PET SCANNER


information about

Device Classification Name

system, tomography, computed, emission

510(k) Number K002584
Device Name ECAT ACCEL 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 08/21/2000
Decision Date 11/16/2000
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