The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Diasonics Mt/p Imaging System.
Device ID | K883516 |
510k Number | K883516 |
Device Name: | DIASONICS MT/P IMAGING SYSTEM |
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 | 1988-08-16 |
Decision Date | 1988-10-07 |