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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 K223287
Device Name Velacur
Applicant
Sonic Incytes
#309-1788 West 5th Ave
Vancouver,  CA V6J 1P2
Applicant Contact Barry Allen
Correspondent
Z & B Enterprises, Inc.
12154 Darnestown Road, #236
Gaithersburg,  MD  20878
Correspondent Contact Rhona Shanker
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received10/25/2022
Decision Date 04/20/2023
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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