INTEGRITY(TM)


Device Classification Name

accelerator, linear, medical

510(k) Number K112613
Device Name INTEGRITY(TM)
Applicant
Elekta Limited
linac house
crawley, west sussex, 

GB

rh10 9rr

Applicant Contact andrew hedges
Correspondent
Elekta Limited
linac house
crawley, west sussex, 

GB

rh10 9rr

Correspodent Contact andrew hedges
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 09/07/2011
Decision Date 12/16/2011
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