VistaScan USB Ultrasound Imaging System

System, Imaging, Pulsed Echo, Ultrasonic

Emagine Solutions Technology, LLC

The following data is part of a premarket notification filed by Emagine Solutions Technology, Llc with the FDA for Vistascan Usb Ultrasound Imaging System.

Pre-market Notification Details

Device IDK192170
510k NumberK192170
Device Name:VistaScan USB Ultrasound Imaging System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Emagine Solutions Technology, LLC 9040 S. Rita Road, Suite 1270 Tucson,  AZ  85747
ContactCourtney Williams
CorrespondentMichelle Lott
Lean RAQA, LLC 12602 N Summer Wind Dr Marana,  AZ  85658
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-12
Decision Date2020-01-23

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