The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Magnetic Resonanc Dvce Visart V 3.5 Software.
| Device ID | K965068 |
| 510k Number | K965068 |
| Device Name: | MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Contact | Javad Seyedzadeh |
| Correspondent | Javad Seyedzadeh TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-18 |
| Decision Date | 1997-07-15 |
| Summary: | summary |