MODIFICATION TO HI-ART TREATMENT SYSTEM
FDA 510(k) clearance K082005 · decided 2008-08-25
Clearance details
- K-number
- K082005
- Device name
- MODIFICATION TO HI-ART TREATMENT SYSTEM
- Applicant
- Tomotherapy Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2008-07-14
- Decision date
- 2008-08-25
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- MUJ
- 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 |
|---|---|---|
| HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. The TomoTherapy HI-ART System is recall (Z-3108-2011) | Accuray Incorporated | 2011-08-31 |
| TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system recall (Z-1649-2011) | TomoTherapy Incorporated | 2011-03-14 |
| ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning an recall (Z-0814-2011) | TomoTherapy Incorporated | 2010-12-27 |
| Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is intended to be used as recall (Z-2219-2010) | TomoTherapy Incorporated | 2010-08-12 |
| TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way recall (Z-2115-2010) | TomoTherapy Incorporated | 2010-08-02 |
| TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming recall (Z-2072-2010) | TomoTherapy Incorporated | 2010-07-22 |