MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER


Device Classification Name

calibrator, dose, radionuclide

510(k) Number K002833
Device Name MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
Original Applicant
STANDARD IMAGING, INC.
7601 murphy dr.
middleton, 
WI 
53562 -2766

Original Contact raymond riddle
Regulation Number 892.1360
Classification Product Code
KPT  
Date Received 09/12/2000
Decision Date 09/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No