# K082005: Modification to HI-Art Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Tomotherapy Incorporated
- Decided: Aug 25, 2008 after 42 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K914698 (1992). 24 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060912: Modification to: HI-Art System, Tomotherapy Incorporated (2006) Summary page 1.
- K926321: Varian C/D-Series Clinacs (Clinac 600 C/D), Varian Assoc., Inc. (1994) Summary page 1.

## Most influential descendants
- K112776: Tomotherapy Treatment System Fast Optimizer (2011), 11 descendants of its own
- K121934: Tomotherapy Treatment System (2012), 10 descendants of its own
- 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

## Recalls of this device
- Jul 13, 2011 · Not classified · Z-3108-2011: As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level
- Jul 7, 2011 · Not classified · Z-3163-2011: TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the TomoMobile Hi-Art System. TomoTherapy has discovered that when attempting t
- Jan 26, 2011 · Not classified · Z-1649-2011: It was determined that the Treatment Planning Station (TPS) can potentially under dose.
- Nov 8, 2010 · Not classified · Z-0814-2011: TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedur
- Jun 23, 2010 · Not classified · Z-2072-2010: An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can
- Feb 22, 2010 · Not classified · Z-2115-2010: In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image.
- Dec 1, 2009 · Not classified · Z-2219-2010: An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station P

## Indications for use
The TomoTherapy HI-ART 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/K082005
Methodology: https://510kreport.com/methodology