The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Cyberknife M6 Fi Sytem, Cyberknife M6 Fm System, Cyberknife M6 Fim System.
| Device ID | K150873 |
| 510k Number | K150873 |
| Device Name: | CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System |
| Classification | Accelerator, Linear, Medical |
| Applicant | ACCURAY INCORPORATED 1310 CHESAPEAKE TERRACE Sunnyvale, CA 94089 |
| Contact | Shweta Kaushik |
| Correspondent | Shweta Kaushik 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 | 2015-04-01 |
| Decision Date | 2015-07-01 |
| Summary: | summary |