# K060912: Modification to: HI-Art System

- Pathway: 510(k) (Special)
- Applicant: Tomotherapy Incorporated
- Decided: Apr 19, 2006 after 16 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K914698 (1992). 22 ancestors in all.
24 later devices descend from it; 2 cite 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)
- K042739: HI-Art System, Tomotherapy Incorporated (2004) Summary page 1.

## Most influential descendants
- 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
- K082775: Prescision Option (2009), 9 descendants of its own
- K090683: Syngo RT Therapist Connect (2009), 7 descendants of its own

## Recalls of this device
- Aug 10, 2009 · Not classified · Z-2243-2009: TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as e
- Oct 14, 2008 · Not classified · Z-0628-2009: TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine spe
- Sep 18, 2008 · Not classified · Z-0339-2009: TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a 
- Feb 22, 2008 · Not classified · Z-1615-2008: Registration adjustment field numbers may appear on printed pages of the Register Tab as nonsense characters or values different than the numbers shown on the Operator Station (OS) display. Setup will

## Indications for use
The TomoTherapy 11I-ART System is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The HI-ART System's planning station or operator 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 [II-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 TomolmageTM (MVCT) scan (a CT using the onboard linear accelerator as the radiation source). This Tomolmage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The Tomohnage (MVCT image) is not for diagnostic use. When patient positioning is complete, the 1ll-ART System is then intended to be used by the therapist to treat the patient using the selected treatment plan. The l1-ART System delivers the radiation therapy treatment, stereotactic radiotherapy, or stereotactic radiosurgery in accordance with the physician approved plan delivered in a helical tomographic pattern.

Source page: https://510kreport.com/device/K060912
Methodology: https://510kreport.com/methodology