Device Classification Name |
system, planning, radiation therapy treatment
|
510(k) Number |
K091146 |
Device Name |
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
Applicant |
ACCURAY, INC. |
1310 ORLEANS DRIVE |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
ANNE SCHLAGENHAFT |
Correspondent |
ACCURAY, INC. |
1310 ORLEANS DRIVE |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
ANNE SCHLAGENHAFT |
Regulation Number | 892.5050
|
Classification Product Code |
|
Date Received | 04/20/2009 |
Decision Date | 05/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|