APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0
FDA 510(k) clearance K063130 · decided 2006-11-02
Clearance details
- K-number
- K063130
- Device name
- APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0
- Applicant
- Toshibamedical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-10-13
- Decision date
- 2006-11-02
- Days to decision
- 20 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 |
|---|---|---|
| Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, recall (Z-0305-2008) | Toshiba American Med Sys Inc | 2008-01-09 |