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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 K192455
Device Name Merge PACS
Applicant
Merge Healthcare Incorporated
900 Walnut Ridge Drive
Hartland,  WI  53209
Applicant Contact Amy Tannenbaum
Correspondent
Merge Healthcare Incorporated
900 Walnut Ridge Drive
Hartland,  WI  53209
Correspondent Contact Amy Tannenbaum
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/09/2019
Decision Date 10/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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