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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K883604
Device Name MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)
Applicant
Medrad, Inc.
Rte.910 Medrad Dr.,
P.O. Box 780
Indianola,  PA  15051
Applicant Contact RUEY C DEMPSEY
Correspondent
Medrad, Inc.
Rte.910 Medrad Dr.,
P.O. Box 780
Indianola,  PA  15051
Correspondent Contact RUEY C DEMPSEY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/24/1988
Decision Date 11/15/1988
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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