Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K131965 |
Device Name |
XVI R5.0 |
Applicant |
Elekta Limited |
LINAC HOUSE, FLEMING WAY |
CRAWLEY, WEST SUSSEX,
GB
RH10 9RR
|
|
Applicant Contact |
ANDREW HEDGES |
Correspondent |
Elekta Limited |
LINAC HOUSE, FLEMING WAY |
CRAWLEY, WEST SUSSEX,
GB
RH10 9RR
|
|
Correspondent Contact |
ANDREW HEDGES |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 06/27/2013 |
Decision Date | 09/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|