The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Aquilion Exceed Lb (tsx-202a/3) V10.6 With Aice-i.
| Device ID | K203042 |
| 510k Number | K203042 |
| Device Name: | Aquilion Exceed LB (TSX-202A/3) V10.6 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, Jr. 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 | 2020-10-06 |
| Decision Date | 2020-12-10 |