The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Vantage Titan 1.5t, Mrt-1510, M-power Gx.
| Device ID | K170412 |
| 510k Number | K170412 |
| Device Name: | Vantage Titan 1.5T, MRT-1510, M-Power GX |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins Toshiba America Medical Systems, 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 | 2017-02-10 |
| Decision Date | 2017-06-07 |
| Summary: | summary |