MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00
FDA 510(k) clearance K072918 · decided 2007-10-29
Clearance details
- K-number
- K072918
- Device name
- MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00
- Applicant
- Toshibamedical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-10-15
- Decision date
- 2007-10-29
- Days to decision
- 14 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 |
|---|---|---|
| Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging recall (Z-0120-2014) | Toshiba American Medical Systems Inc | 2013-10-30 |
| PVT-681MV Endocavitary Transducer used with the Aplio XG and Xario XG Ultrasound Systems. recall (Z-1997-2010) | Toshiba American Medical Systems Inc | 2010-07-13 |
| PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultra recall (Z-1100-2010) | Toshiba American Medical Systems Inc | 2010-03-11 |