# Tomotherapy Incorporated

- Location (FDA's records): Madison, WI
- FDA decisions: 6 (2003–2011): 6 510(k) clearances
- Product codes: MUJ (4), IYE (2)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tomo Therapy, Inc.: 1 (https://510kreport.com/company/tomo-therapy)
- Varian Assoc., Inc.: 1 (https://510kreport.com/company/varian-assoc)

## Firms that cite its devices most
- Accuray Incorporated: 1 (https://510kreport.com/company/accuray)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Its most-cited devices
- K082005: Modification to HI-Art Treatment System (2008), cited by 2
- K060912: Modification to: HI-Art System (2006), cited by 2
- K042739: HI-Art System (2004), cited by 1
- K112776: Tomotherapy Treatment System Fast Optimizer (2011), cited by 1
- K033347: Modification to: HI-Art System (2003), cited by 1

## Recent decisions
- K112776: Tomotherapy Treatment System Fast Optimizer (Dec 22, 2011)
- K112446: Tomotherapy Treatment System (Oct 7, 2011)
- K082005: Modification to HI-Art Treatment System (Aug 25, 2008)
- K060912: Modification to: HI-Art System (Apr 19, 2006)
- K042739: HI-Art System (Nov 3, 2004)
- K033347: Modification to: HI-Art System (Nov 12, 2003)

Source page: https://510kreport.com/company/tomotherapy