The following data is part of a premarket notification filed by Accuray, Inc. with the FDA for Motion Tracking.
Device ID | K020294 |
510k Number | K020294 |
Device Name: | MOTION TRACKING |
Classification | Accelerator, Linear, Medical |
Applicant | ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
Contact | Donald E Caddes |
Correspondent | Donald E Caddes ACCURAY, INC. 570 DEL REY AVE. Sunnyvale, CA 94085 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-28 |
Decision Date | 2002-04-22 |
Summary: | summary |