AQUILION ONE
FDA 510(k) clearance K113466 · decided 2012-04-10
Clearance details
- K-number
- K113466
- Device name
- AQUILION ONE
- Applicant
- Toshiba Medical Systems Coporation, Japan
- Decision
- Substantially Equivalent
- Date received
- 2011-11-22
- Decision date
- 2012-04-10
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tustin, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Toshiba Aquilion CT System TSX-301A recall (Z-0014-2016) | Toshiba American Medical Systems Inc | 2015-10-09 |
| Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is recall (Z-0472-2015) | Toshiba American Medical Systems Inc | 2014-11-26 |
| TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Compu recall (Z-1113-2014) | Toshiba American Medical Systems Inc | 2014-03-03 |