CLARITY OBP SYSTEM


Device Classification Name

accelerator, linear, medical

510(k) Number K111332
Device Name CLARITY OBP SYSTEM
Applicant
ELEKTA LTD.
2050 bleury, suite 200
montreal, 

CA

h3a 2j5

Applicant Contact george papagiannis
Correspondent
ELEKTA LTD.
2050 bleury, suite 200
montreal, 

CA

h3a 2j5

Correspodent Contact george papagiannis
Regulation Number 892.5050
Classification Product Code
IYE  
Subsequent Product Codes
IWB   KPQ  
Date Received 05/11/2011
Decision Date 01/30/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No