The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Vantage Titan Hsr.
| Device ID | K112003 |
| 510k Number | K112003 |
| Device Name: | VANTAGE TITAN HSR |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION 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 | Yes |
| Date Received | 2011-07-13 |
| Decision Date | 2011-12-02 |
| Summary: | summary |