NEMIO XG, SAA-580A
FDA 510(k) clearance K061605 · decided 2006-06-22
Clearance details
- K-number
- K061605
- Device name
- NEMIO XG, SAA-580A
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2006-06-09
- Decision date
- 2006-06-22
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5 recall (Z-0254-2008) | Toshiba American Med Sys Inc | 2007-11-17 |
| Nemio XG, ultrasound system, SSA-590A with version 1.5 software, Toshiba American Medical recall (Z-0771-2007) | Toshiba American Med Sys Inc | 2007-05-05 |