MODEL 1133 IVD PC VERSION


Device Classification Name

accelerator, linear, medical

510(k) Number K021463
Device Name MODEL 1133 IVD PC VERSION
Original Applicant
SUN NUCLEAR CORP.
425-a pineda court
melbourne, 
FL 
32940

Original Contact jim mixon
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 05/07/2002
Decision Date 06/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No