Imagio Ultrasound Imaging System

System, Imaging, Pulsed Doppler, Ultrasonic

Seno Medical Instruments, Inc.

The following data is part of a premarket notification filed by Seno Medical Instruments, Inc. with the FDA for Imagio Ultrasound Imaging System.

Pre-market Notification Details

Device IDK182628
510k NumberK182628
Device Name:Imagio Ultrasound Imaging System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Seno Medical Instruments, Inc. 8023 Vantage Drive, Suite 1000 San Antonio,  TX  78240
ContactKatherin Harris
CorrespondentAnn Waterhouse
Seno Medical Instruments, Inc. 8023 Vantage Drive, Suite 1000 San Antonio,  TX  78240
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-24
Decision Date2019-03-05

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