The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aquilion Prime Sp (tsx-303b8) V10.2 With Aice-i.
| Device ID | K192832 |
| 510k Number | K192832 |
| Device Name: | Aquilion Prime SP (TSX-303B8) V10.2 With AiCE-i |
| 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 | 2019-10-02 |
| Decision Date | 2020-02-21 |