Device Classification Name |
accelerator, linear, medical
|
510(k) Number |
K122137 |
Device Name |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM |
Applicant |
ACCURAY INCORPORATED |
1310 CHESAPEAKE TERRACE |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
ANNE SCHLAGENHAFT |
Correspondent |
ACCURAY INCORPORATED |
1310 CHESAPEAKE TERRACE |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
ANNE SCHLAGENHAFT |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 07/18/2012 |
Decision Date | 10/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|