MODIFICATION TO: HI-ART SYSTEM
FDA 510(k) clearance K060912 · decided 2006-04-19
Clearance details
- K-number
- K060912
- Device name
- MODIFICATION TO: HI-ART SYSTEM
- Applicant
- Tomotherapy Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2006-04-03
- Decision date
- 2006-04-19
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TomoTherapy Hi-Art System, Version 3.X ThomoTherapy Incorporated 1240 Deming Way, Madison, recall (Z-2243-2009) | TomoTherapy Incorporated | 2009-09-21 |
| TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affect recall (Z-0628-2009) | TomoTherapy Incorporated | 2009-01-22 |
| TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications recall (Z-0339-2009) | TomoTherapy Incorporated | 2009-01-05 |
| TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. T recall (Z-1615-2008) | TomoTherapy Incorporated | 2008-08-24 |