K213504 is an FDA 510(k) clearance for the Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Canon Medical Systems Corporation (Otawara-Shi, JP). The FDA issued a Cleared decision on June 16, 2022, 227 days after receiving the submission on November 1, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K213504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2021 |
| Decision Date | June 16, 2022 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |