The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Vantage Galan 3t, Mrt-3020, V4.0.
| Device ID | K162183 |
| 510k Number | K162183 |
| Device Name: | Vantage Galan 3T, MRT-3020, V4.0 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 1385 SHIMOISHIGAMI Otawara-shi, JP 324-8550 |
| Contact | Paul Biggins |
| Correspondent | Janine Faith 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 | 2016-08-04 |
| Decision Date | 2016-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670102615 | K162183 | 000 |