The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Vantage Titan, Model Mrt-1504/s3.
| Device ID | K080038 |
| 510k Number | K080038 |
| Device Name: | VANTAGE TITAN, MODEL MRT-1504/S3 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-01-07 |
| Decision Date | 2008-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670101564 | K080038 | 000 |
| 04987670101557 | K080038 | 000 |
| 04987670101533 | K080038 | 000 |
| 04987670101502 | K080038 | 000 |
| 04987670101489 | K080038 | 000 |