The following data is part of a premarket notification filed by Accuray Incorporated with the FDA for Tomotherapy Treatment Delivery System With Idms.
| Device ID | K171837 |
| 510k Number | K171837 |
| Device Name: | TomoTherapy Treatment Delivery System With IDMS |
| Classification | Accelerator, Linear, Medical |
| Applicant | Accuray Incorporated 1240 Deming Way Madison, WI 53717 |
| Contact | Keith Picker |
| Correspondent | Keith Picker Accuray Incorporated 1240 Deming Way Madison, WI 53717 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-20 |
| Decision Date | 2017-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811376030528 | K171837 | 000 |
| 00811376030511 | K171837 | 000 |
| 00811376030504 | K171837 | 000 |