The following data is part of a premarket notification filed by Accuray, Inc. with the FDA for Cyberknife System.
| Device ID | K011024 |
| 510k Number | K011024 |
| Device Name: | CYBERKNIFE SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
| Contact | E. Bruce Floyd |
| Correspondent | E. Bruce Floyd ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2001-08-10 |