XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
FDA 510(k) clearance K050380 · decided 2005-02-23
Clearance details
- K-number
- K050380
- Device name
- XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2005-02-15
- Decision date
- 2005-02-23
- Days to decision
- 8 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 |
|---|---|---|
| Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging recall (Z-0119-2014) | Toshiba American Medical Systems Inc | 2013-10-30 |
| Xario; SSA-660A; software version 1.0 and later recall (Z-1173-2010) | Toshiba American Medical Systems Inc | 2010-03-19 |