The following data is part of a premarket notification filed by Accuray, Inc. with the FDA for The Cyberknife System For Stereotactic Radiosurgery/ Radiotherapy V2.1.
| Device ID | K000478 |
| 510k Number | K000478 |
| Device Name: | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
| Contact | Luanne Ng |
| Correspondent | Luanne Ng ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-14 |
| Decision Date | 2000-04-19 |