The following data is part of a premarket notification filed by Accuray, Inc. with the FDA for Modification To Cyberknife Robotic Radiosurgery System.
| Device ID | K091146 |
| 510k Number | K091146 |
| Device Name: | MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ACCURAY, INC. 1310 ORLEANS DRIVE Sunnyvale, CA 94089 |
| Contact | Anne Schlagenhaft |
| Correspondent | Anne Schlagenhaft ACCURAY, INC. 1310 ORLEANS DRIVE Sunnyvale, CA 94089 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-05-01 |
| Summary: | summary |