FORTE GAMMA CAMERA SYSTEM

Device Classification Name

system, tomography, computed, emission

510(k) Number K033254
Device Name FORTE GAMMA CAMERA SYSTEM
Applicant
ADAC LABORATORIES
540 alder dr.
milpitas, 
CA 
95035

Applicant Contact joy m sacmar
Regulation Number 892.1200
Classification Product Code
KPS  
Date Received 10/08/2003
Decision Date 10/22/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No