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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K891541
Device Name MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.
Applicant
Diasonics, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Applicant Contact JAVAD SEYEDZADEH
Correspondent
Diasonics, Inc.
280 Utah Ave.
S. San Francisco,  CA  94080
Correspondent Contact JAVAD SEYEDZADEH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/17/1989
Decision Date 05/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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