The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Synchrony Respiratory Tracking System.
Device ID | K120233 |
510k Number | K120233 |
Device Name: | SYNCHRONY RESPIRATORY TRACKING 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 | 2012-01-25 |
Decision Date | 2012-03-09 |
Summary: | summary |