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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 K932403
Device Name AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN
Applicant
Medrad, Inc.
Rte.910 Medrad Dr.,
P.O. Box 780
Indianola,  PA  15051
Applicant Contact JOHN E STEVENS
Correspondent
Medrad, Inc.
Rte.910 Medrad Dr.,
P.O. Box 780
Indianola,  PA  15051
Correspondent Contact JOHN E STEVENS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/03/1993
Decision Date 02/24/1994
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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