# K033347: Modification to: HI-Art System

- Pathway: 510(k) (Special)
- Applicant: Tomotherapy Incorporated
- Decided: Nov 12, 2003 after 23 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914698 (1992). 20 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013673: HI-Art System, Tomo Therapy, Inc. (2002)

## Most influential descendants
- K042739: HI-Art System (2004), 25 descendants of its own
- K060912: Modification to: HI-Art System (2006), 24 descendants of its own
- K082005: Modification to HI-Art Treatment System (2008), 13 descendants of its own
- K112776: Tomotherapy Treatment System Fast Optimizer (2011), 11 descendants of its own
- K121934: Tomotherapy Treatment System (2012), 10 descendants of its own

## Indications for use
The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT) for the treatment of cancer. The HI-ART System provides precise delivery of radiation to tumors while minimizing the delivery of radiation to vital healthy tissue. The HI-ART System’s planning station is intended to be used by the physiciadoncologist to prescribe a radiation therapy plan for a particular patient. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system’s operator station and status console is then intended to be used by the therapist to select and implement the patient’s treatment plan. The treatment process will begin by performing a TomoImagem (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This TomoImage W C T ) will confirm that the patient’s position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT image) is not for diagnostic use. When patient positioning is complete, the HI-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy treatment in accordance with the physician approved plan using IMRT techniques delivered in a helical tomographic pattern.

Source page: https://510kreport.com/device/K033347
Methodology: https://510kreport.com/methodology