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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 K884816
Device Name ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY
Applicant
DIASONICS, INC.
280 UTAH AVE.
S. SAN FRANCISCO,  CA  94080
Applicant Contact BEN KHOSRAVI
Correspondent
DIASONICS, INC.
280 UTAH AVE.
S. SAN FRANCISCO,  CA  94080
Correspondent Contact BEN KHOSRAVI
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/17/1988
Decision Date 02/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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