SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K022400 · decided 2002-08-06
Clearance details
- K-number
- K022400
- Device name
- SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Toshiba America Medical Systems, In.C
- Decision
- Substantially Equivalent
- Date received
- 2002-07-23
- Decision date
- 2002-08-06
- Days to decision
- 14 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 50 Digital Ultrasound System, SSA-700A with version 6 software recall (Z-0986-2007) | Toshiba American Med Sys Inc | 2007-06-27 |