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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 K192170
Device Name VistaScan USB Ultrasound Imaging System
Applicant
Emagine Solutions Technology, LLC
9040 S Rita Rd.
Suite 1270
Tucson,  AZ  85747
Applicant Contact Courtney Williams
Correspondent
leanRAQA, LLC
12602 N Summer Wind Dr.
Marana,  AZ  85658
Correspondent Contact Michelle Lott
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received08/12/2019
Decision Date 01/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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