The following data is part of a premarket notification filed by Accuray, Inc. with the FDA for The Cyberknife System For Stereotactic Radiosurgery/radiotherapy.
| Device ID | K984563 |
| 510k Number | K984563 |
| Device Name: | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
| Contact | Luanne Termeer |
| Correspondent | Luanne Termeer ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-23 |
| Decision Date | 1999-07-14 |
| Summary: | summary |