APLIO MX SSA-780A, VERSION 1.0
FDA 510(k) clearance K092948 · decided 2009-10-09
Clearance details
- K-number
- K092948
- Device name
- APLIO MX SSA-780A, VERSION 1.0
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2009-09-24
- Decision date
- 2009-10-09
- Days to decision
- 15 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 |
|---|---|---|
| Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging recall (Z-0121-2014) | Toshiba American Medical Systems Inc | 2013-10-30 |