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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 K213275
Device Name EchoGo Core (2.0)
Applicant
Ultromics Limited
4630 Kingsgate, Cascade Way
Oxford Business Park South
Oxford,  GB OX4 2SU
Applicant Contact Jaco Jacobs
Correspondent
Ultromics Limited
4630 Kingsgate, Cascade Way
Oxford Business Park South
Oxford,  GB OX4 2SU
Correspondent Contact Jaco Jacobs
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/30/2021
Decision Date 12/20/2021
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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