The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Cyberknife Robotic Radiosurgery System Cyberknife Vsi Robotic Radiosurgery System.
| Device ID | K122137 |
| 510k Number | K122137 |
| Device Name: | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Anne Schlagenhaft |
| Correspondent | Anne Schlagenhaft ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-18 |
| Decision Date | 2012-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811376030498 | K122137 | 000 |
| 00811376030467 | K122137 | 000 |
| 00811376030450 | K122137 | 000 |
| 00811376030443 | K122137 | 000 |
| 00811376030436 | K122137 | 000 |
| 00811376030429 | K122137 | 000 |