The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation, Japan with the FDA for Vantage Titan 3t.
| Device ID | K102489 |
| 510k Number | K102489 |
| Device Name: | VANTAGE TITAN 3T |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2241 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2241 MICHELLE DR Tustin, CA 92780 |
| Product Code | LNH |
| Subsequent Product Code | LNI |
| Subsequent Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-08-31 |
| Decision Date | 2011-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020201 | K102489 | 000 |