# K013673: HI-Art System

- Pathway: 510(k) (Traditional)
- Applicant: Tomo Therapy, Inc.
- Decided: Jan 28, 2002 after 83 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 4 generations back to K914698 (1992). 19 ancestors in all.
27 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)
- K002237: P3IMRT TM, Adac Laboratories (2001) Summary page 1.
- K993923: Adac PINNACLE3TM Radiation Therapy Planning System, Adac Laboratories (2000) Summary page 1.
- K923851: Acqsim Simulator/Localizer, Philips Medical Systems (Cleveland), Inc. (1992) Summary page 1.
- K983256: Advantage Windows (AW) Fusion, GE Medical Systems (1998) Summary page 1.
- K003437: Odyssey LX, Model 211320, Philips Medical Systems (Cleveland), Inc. (2001) Summary page 1.
- K982502: Genesis Imrt Linear Accelerator, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Most influential descendants
- K033347: Modification to: HI-Art System (2003), 26 descendants of its own
- 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

## 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 physician/oncologist 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 an MVCT scan (a CT using the onboard linear accelerator as the radiation source). This MVCT image will confirm that the patient’s position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The 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/K013673
Methodology: https://510kreport.com/methodology