The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Vantage Titan With Helios Gradient Model Mrt-1504/us.
| Device ID | K122613 |
| 510k Number | K122613 |
| Device Name: | VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. 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 | 2012-08-27 |
| Decision Date | 2012-12-13 |
| Summary: | summary |