Aquilion Prime SP, TSX-303B/1, v8.4
FDA 510(k) clearance K172188 · decided 2017-10-06
Clearance details
- K-number
- K172188
- Device name
- Aquilion Prime SP, TSX-303B/1, v8.4
- Applicant
- Toshiba Medical Systems Coroporation
- Decision
- Substantially Equivalent
- Date received
- 2017-07-20
- Decision date
- 2017-10-06
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Otawara-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Canon Aquilion Prime SP, Model TSX-303B recall (Z-1724-2020) | Canon Medical System, USA, INC. | 2020-04-10 |