SENO ADVANTAGE
FDA 510(k) clearance K033400 · decided 2003-12-04
Clearance details
- K-number
- K033400
- Device name
- SENO ADVANTAGE
- Applicant
- Ge Medical Systems W-400
- Decision
- Substantially Equivalent
- Date received
- 2003-10-24
- Decision date
- 2003-12-04
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 518368 recall (Z-2257-2013) | GE Healthcare, LLC | 2013-09-19 |
| GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A med recall (Z-0125-2013) | GE Healthcare, LLC | 2012-10-24 |
| GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Adv recall (Z-0095-2013) | GE Healthcare, LLC | 2012-10-19 |
| GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healt recall (Z-3012-2011) | GE Healthcare, LLC | 2011-08-12 |
| GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 recall (Z-0476-2011) | GE Healthcare, LLC | 2010-11-26 |
| GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 Seno recall (Z-1747-2010) | Ge Healthcare, Llc | 2010-06-02 |