The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Magnetic Resonance Device Accessory Software 4.0..
| Device ID | K891541 |
| 510k Number | K891541 |
| Device Name: | MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0. |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | DIASONICS, INC. 280 UTAH AVE. S. San Francisco, CA 94080 |
| Contact | Javad Seyedzadeh |
| Correspondent | Javad Seyedzadeh DIASONICS, INC. 280 UTAH AVE. S. San Francisco, CA 94080 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-05-11 |