The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Opart (including Opart Ultra And Ultra Gradient Upgrade Kit).
| Device ID | K023207 |
| 510k Number | K023207 |
| Device Name: | OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. Tustin, CA 92780 |
| 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 | 2002-09-25 |
| Decision Date | 2002-10-09 |
| Summary: | summary |