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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 K182290
Device Name IBM iConnect Access
Applicant
Merge Healthcare Incorporated
900 Walnut Ridge Drive
Hartland,  WI  53209
Applicant Contact Tracey Fox
Correspondent
Merge Healthcare Incorporated
900 Walnut Ridge Drive
Hartland,  WI  53209
Correspondent Contact Tracey Fox
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/23/2018
Decision Date 09/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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