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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K191171
Device Name EchoGo Core
Applicant
Ultromics, Ltd.
Stansfeld Park Quarry Rd.
Oxford,  GB OX3 8SB
Applicant Contact Melissa Clark
Correspondent
Ultromics, Ltd.
Stansfeld Park Quarry Rd.
Oxford,  GB OX3 8SB
Correspondent Contact Melissa Clark
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/01/2019
Decision Date 11/13/2019
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
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