ECLIPSE 6.5
FDA 510(k) clearance K010975 · decided 2001-05-02
Clearance details
- K-number
- K010975
- Device name
- ECLIPSE 6.5
- Applicant
- Varian Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-02
- Decision date
- 2001-05-02
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7 recall (Z-0861-2009) | Varian Medical Systems Oncology Systems | 2009-02-20 |
| Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and e recall (Z-2308-2008) | Varian Medical Systems Oncology Systems | 2008-09-17 |
| Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and inclu recall (Z-0393-06) | Varian Medical Systems Inc | 2006-01-18 |