# K121934: Tomotherapy Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Accuray Incorporated
- Decided: Aug 29, 2012 after 58 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K914698 (1992). 26 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112776: Tomotherapy Treatment System Fast Optimizer, Tomotherapy Incorporated (2011)

## Most influential descendants
- K161146: Radixact Treatment Delivery System (2016), 3 descendants of its own
- K161136: Precision Treatment Planning System (2016), 2 descendants of its own
- K202412: ClearRT Helical kVCT for the Radixact Treatment Delivery System (2020), 1 descendant of its own
- K171086: Accuray Precision Treatment Planning System (2017), 1 descendant of its own
- K223159: Radixact Treatment Delivery System (2023), 0 descendants of its own

## Recalls of this device
- Dec 10, 2020 · Class II · Z-0784-2021: "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
- Nov 17, 2017 · Class II · Z-0288-2018: Uncontrolled couch Z-axis movement (descent)
- Nov 17, 2017 · Class II · Z-0289-2018: Uncontrolled couch Z-axis movement (descent)
- Nov 17, 2017 · Class II · Z-0286-2018: Uncontrolled couch Z-axis movement (descent)
- Nov 17, 2017 · Class II · Z-0287-2018: Uncontrolled couch Z-axis movement (descent)
- Nov 21, 2014 · Class II · Z-0507-2015: Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorre
- Jul 17, 2014 · Class II · Z-2239-2014: Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these s
- Jul 16, 2014 · Class II · Z-2240-2014: Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versio

## Indications for use
The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.

Source page: https://510kreport.com/device/K121934
Methodology: https://510kreport.com/methodology