RADIONICS VARILINK 2


Device Classification Name

accelerator, linear, medical

510(k) Number K023519
Device Name RADIONICS VARILINK 2
Original Applicant
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
22 terry ave.
burlington, 
MA 
01803

Original Contact kevin j o’connell
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 10/21/2002
Decision Date 01/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No