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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 K960901
Device Name MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL
Applicant
MEDRAD, INC.
14 MEDRAD DR.
INDIANOLA,  PA  15051 -0780
Applicant Contact RODNEY J RYLANDS
Correspondent
MEDRAD, INC.
14 MEDRAD DR.
INDIANOLA,  PA  15051 -0780
Correspondent Contact RODNEY J RYLANDS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/05/1996
Decision Date 05/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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