APEX


Device Classification Name

block, beam-shaping, radiation therapy

510(k) Number K111676
Device Name APEX
Applicant
Elekta Limited
linac house, fleming way
crawley, 

GB

rh10 9rr

Applicant Contact patrick hull
Correspondent
Elekta Limited
linac house, fleming way
crawley, 

GB

rh10 9rr

Correspodent Contact patrick hull
Regulation Number 892.5710
Classification Product Code
IXI  
Date Received 06/15/2011
Decision Date 09/30/2011
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