The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Vantage Titan 3t.
| Device ID | K152371 |
| 510k Number | K152371 |
| Device Name: | Vantage Titan 3T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara, JP |
| Contact | Janine Reyes |
| Correspondent | Janine F. Reyes 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 | 2015-08-21 |
| Decision Date | 2015-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670101649 | K152371 | 000 |
| 04987670101526 | K152371 | 000 |
| 04987670101496 | K152371 | 000 |