Device Classification Name |
Accelerator, Linear, Medical
|
510(k) Number |
K080585 |
Device Name |
DESKTOP PRO |
Applicant |
ELEKTA LTD. |
LINAC HOUSE |
FLEMING WAY, CRAWLEY |
WEST SUSSEX,
GB
RH10 9RR
|
|
Applicant Contact |
PATRICK T.M. HULL |
Correspondent |
ELEKTA LTD. |
LINAC HOUSE |
FLEMING WAY, CRAWLEY |
WEST SUSSEX,
GB
RH10 9RR
|
|
Correspondent Contact |
PATRICK T.M. HULL |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 03/03/2008 |
Decision Date | 06/11/2008 |
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
|
|
|