VARISEED 7.1
FDA 510(k) clearance K030534 · decided 2003-05-21
Clearance details
- K-number
- K030534
- Device name
- VARISEED 7.1
- Applicant
- Varian Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2003-02-20
- Decision date
- 2003-05-21
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KXK
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Charlottesville, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VariSeed 7.1, software application, part number H62, manufactured by Varian Medical System recall (Z-1385-2012) | Varian Medical Systems, Inc. | 2012-04-10 |