The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Excelart With Pianissimo, Model Mrt-1500/p3.
Device ID | K010129 |
510k Number | K010129 |
Device Name: | EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 |
Classification | System, Nuclear Magnetic Resonance Spectroscopic |
Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
Contact | Paul Biggins |
Correspondent | Paul Biggins TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
Product Code | LNI |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-01-16 |
Decision Date | 2001-04-05 |