2 BASIC


Device Classification Name

accelerator, linear, medical

510(k) Number K030175
Device Name 2 BASIC
Original Applicant
CAPINTEC, INC.
540 alpha dr.
pittsburgh, 
PA 
15238

Original Contact mary anne dell
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 01/17/2003
Decision Date 04/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No