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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 K932292
Device Name AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS
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 Received05/10/1993
Decision Date 08/26/1993
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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