The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Vantage Titan 1.5t, Mrt-1510, V3.6 Software.
Device ID | K160632 |
510k Number | K160632 |
Device Name: | Vantage Titan 1.5T, MRT-1510, V3.6 Software |
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 | 2016-03-07 |
Decision Date | 2016-08-23 |
Summary: | summary |