The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aquilion One (tsx-306a/3) V10.12 With Spectral Imaging System, Vitrea Software Package, Vstp-001a.
| Device ID | K213504 |
| 510k Number | K213504 |
| Device Name: | Aquilion ONE (TSX-306A/3) V10.12 With Spectral Imaging System, Vitrea Software Package, VSTP-001A |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Canon Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Orlando Tadeo Canon Medical Systems USA 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-01 |
| Decision Date | 2022-06-16 |