APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
FDA 510(k) clearance K091295 · decided 2009-05-15
Clearance details
- K-number
- K091295
- Device name
- APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2009-05-04
- Decision date
- 2009-05-15
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- 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 |
|---|---|---|
| Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging recall (Z-0122-2014) | Toshiba American Medical Systems Inc | 2013-10-30 |
| Aplio XG model SSA-790A Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound syste recall (Z-2981-2011) | Toshiba American Medical Systems Inc | 2011-08-10 |