ExactVu High Resolution Micro-Ultrasound System

System, Imaging, Pulsed Echo, Ultrasonic

Exact Imaging

The following data is part of a premarket notification filed by Exact Imaging with the FDA for Exactvu High Resolution Micro-ultrasound System.

Pre-market Notification Details

Device IDK162972
510k NumberK162972
Device Name:ExactVu High Resolution Micro-Ultrasound System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Exact Imaging 7676 Woodbine Avenue Unit 15 Markham,  CA L3r 2n2
ContactKarina Torres
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeOIJ
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-10-25
Decision Date2016-12-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20628055481076 K162972 000
00628055481041 K162972 000
00628055481034 K162972 000
00628055481027 K162972 000
00628055481010 K162972 000

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