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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 K934318
Device Name DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL
Applicant
Diagnostic Instrument Corp.
201 Belcourt Ln.
Aurora,  OH  44202
Applicant Contact R.M. BENEDICT
Correspondent
Diagnostic Instrument Corp.
201 Belcourt Ln.
Aurora,  OH  44202
Correspondent Contact R.M. BENEDICT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/01/1993
Decision Date 08/22/1994
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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