SSA-770A, APLIO VERSION 5.5
FDA 510(k) clearance K041499 · decided 2004-06-10
Clearance details
- K-number
- K041499
- Device name
- SSA-770A, APLIO VERSION 5.5
- Applicant
- Toshibamedical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-06-07
- Decision date
- 2004-06-10
- Days to decision
- 3 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 50; SSA-700A; software version 5.5r002 recall (Z-1171-2010) | Toshiba American Medical Systems Inc | 2010-03-19 |
| Aplio 80; SSA-770A; software version 5.5r002 recall (Z-1172-2010) | Toshiba American Medical Systems Inc | 2010-03-19 |
| Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software recall (Z-0985-2007) | Toshiba American Med Sys Inc | 2007-06-27 |