TomoTherapy Incorporated
FDA Regulatory Profile
TomoTherapy Incorporated appears in FDA public data with 3 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0507-2015, Class II) was initiated on November 21, 2014. Its most recent 510(k) clearance was granted on December 22, 2011.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0507-2015 | Class II | TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5 | November 21, 2014 |
| Z-2239-2014 | Class II | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2 | July 17, 2014 |
| Z-2240-2014 | Class II | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0 | July 16, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K112776 | TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER | December 22, 2011 |
| K112446 | TOMOTHERAPY TREATMENT SYSTEM | October 7, 2011 |
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM | August 25, 2008 |
| K060912 | MODIFICATION TO: HI-ART SYSTEM | April 19, 2006 |
| K042739 | HI-ART SYSTEM | November 3, 2004 |
| K033347 | MODIFICATION TO: HI-ART SYSTEM | November 12, 2003 |