SONIXTABLET ULTRASOUND SCANNER

System, Imaging, Pulsed Doppler, Ultrasonic

UltraSonix Medical Corporation

The following data is part of a premarket notification filed by Ultrasonix Medical Corporation with the FDA for Sonixtablet Ultrasound Scanner.

Pre-market Notification Details

Device IDK113663
510k NumberK113663
Device Name:SONIXTABLET ULTRASOUND SCANNER
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant UltraSonix Medical Corporation 130-4311 VIKING WAY Richmond, British Columbia,  CA V6v 2k9
ContactChas Yu
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYN  
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-12-13
Decision Date2012-01-25
Summary:summary

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