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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer-assisted diagnostic software for lesions suspicious for cancer
510(k) Number K201555
Device Name EchoGo Pro
Applicant
Ultromics Ltd
4630 Kingsgate, Cascade Way, Oxford Business Park South
Oxford,  GB OX4 2SU
Applicant Contact Melissa Clark
Correspondent
Ultromics Ltd
4630 Kingsgate, Cascade Way, Oxford Business Park South
Oxford,  GB OX4 2SU
Correspondent Contact Melissa Clark
Regulation Number892.2060
Classification Product Code
POK  
Date Received06/10/2020
Decision Date 12/18/2020
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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