The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Excelart With Pianissimo Xg/ag Spin Edition, Model Mrt-1501/p3, P2.
| Device ID | K023511 |
| 510k Number | K023511 |
| Device Name: | EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Michaela Mahl |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-10-21 |
| Decision Date | 2002-11-05 |
| Summary: | summary |