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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 K914366
Device Name MEDRAD PATHFINDER HR ROADMAPPING SYSTEM
Applicant
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Applicant Contact JAN E.BURTIK
Correspondent
Medrad, Inc.
271 Kappa Dr.
Pittsburgh,  PA  15238
Correspondent Contact JAN E.BURTIK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/01/1991
Decision Date 02/27/1992
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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