The following data is part of a premarket notification filed by Accuray, Inc. with the FDA for Cyberknife System For Sterotactic Radiosurgery/radiotherapy.
| Device ID | K032345 |
| 510k Number | K032345 |
| Device Name: | CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
| Contact | Anne Schlagenhaft |
| Correspondent | Anne Schlagenhaft ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-30 |
| Decision Date | 2003-09-03 |
| Summary: | summary |