NOVAC 11


Device Classification Name

accelerator, linear, medical

510(k) Number K112286
Device Name NOVAC 11
Applicant
NEW RADIANT TECHNOLOGY S.P.A.
5 timber lane
north reading, 
MA 
01864

Applicant Contact maureen o’connel
Correspondent
NEW RADIANT TECHNOLOGY S.P.A.
5 timber lane
north reading, 
MA 
01864

Correspodent Contact maureen o’connel
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 08/09/2011
Decision Date 04/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No