The following data is part of a premarket notification filed by Canon Medical Systems Corporation with the FDA for Vantage Fortian 1.5t, Mrt-1550, V8.0 With Aice Reconstruction Processing Unit For Mr.
| Device ID | K213305 |
| 510k Number | K213305 |
| Device Name: | Vantage Fortian 1.5T, MRT-1550, V8.0 With AiCE Reconstruction Processing Unit For MR |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Canon Medical Systems Corporation 1385 Shimoshigami Otawara-shi, JP 324-8550 |
| Contact | Janine F. Reyes |
| Correspondent | Janine F. Reyes Canon Medical Systems U.S.A, Inc. 2441 Michelle Drive Tustin, CA 92780 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-04 |
| Decision Date | 2021-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670104831 | K213305 | 000 |