The following data is part of a premarket notification filed by Accuray, Inc. with the FDA for Cyberknife System For Stereotactic Radiosurgery/radiotherapy.
| Device ID | K041315 |
| 510k Number | K041315 |
| Device Name: | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCURAY, INC. 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Anne Schlagenhaft |
| Correspondent | Anne Schlagenhaft ACCURAY, INC. 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-17 |
| Decision Date | 2004-06-10 |
| Summary: | summary |