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 |