The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Cyberknife Robotic Radiosurgery System.
| Device ID | K102650 |
| 510k Number | K102650 |
| Device Name: | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Anne Schlagenhaft |
| Correspondent | Anne Schlagenhaft ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-14 |
| Decision Date | 2010-11-17 |
| Summary: | summary |