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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K181574
Device Name Uscan
Applicant
EchoNous, Inc.
8310 154th Ave NE
Building B, Suite 200
Redmond,  VA  98052
Applicant Contact Trish Liau
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received06/15/2018
Decision Date 07/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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