# K171837: TomoTherapy Treatment Delivery System with iDMS

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Jul 25, 2017 after 35 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K914698 (1992). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121934: Tomotherapy Treatment System, Accuray Incorporated (2012) Summary page 4.

## Recalls of this device
- Dec 10, 2020 · Class II · Z-0785-2021: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.

## Indications for use
The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

Source page: https://510kreport.com/device/K171837
Methodology: https://510kreport.com/methodology