APLIO ARTIDA V2.0 SSH-880CV
FDA 510(k) clearance K090158 · decided 2009-02-06
Clearance details
- K-number
- K090158
- Device name
- APLIO ARTIDA V2.0 SSH-880CV
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2009-01-22
- Decision date
- 2009-02-06
- 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 Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc recall (Z-2897-2011) | Toshiba American Medical Systems Inc | 2011-07-29 |
| Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound recall (Z-2203-2011) | Toshiba American Medical Systems Inc | 2011-05-19 |
| Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System recall (Z-2179-2011) | Toshiba American Medical Systems Inc | 2011-05-10 |
| SSH-880CV Aplio Artida; System, Diagnostic Ultrasound recall (Z-1498-2011) | Toshiba American Medical Systems Inc | 2011-03-03 |
| SSH-880CV Aplio Artida System recall (Z-1955-2010) | Toshiba American Medical Systems Inc | 2010-07-06 |