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 |