AGILITY


Device Classification Name

accelerator, linear, medical

510(k) Number K121328
Device Name AGILITY
Applicant
ELEKTA LTD.
fleming way
linac house
crawley, west sussex, 

GB

rh10 9rr

Applicant Contact patrick hull
Correspondent
ELEKTA LTD.
fleming way
linac house
crawley, west sussex, 

GB

rh10 9rr

Correspodent Contact patrick hull
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 05/03/2012
Decision Date 06/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls