Ultrasound System SONIMAGE MX1

System, Imaging, Pulsed Echo, Ultrasonic

Konica Minolta, Inc.

The following data is part of a premarket notification filed by Konica Minolta, Inc. with the FDA for Ultrasound System Sonimage Mx1.

Pre-market Notification Details

Device IDK180084
510k NumberK180084
Device Name:Ultrasound System SONIMAGE MX1
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Konica Minolta, Inc. 1 Sakura-machi Hino-shi,  JP 191-8511
ContactTsutomu Fukui
CorrespondentRussell D Munves
Storch Amini PC 140 East 45th Street 25th Floor Newyork,  NY  10017
Product CodeIYO  
Subsequent Product CodeITX
Subsequent Product CodeIYN
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-11
Decision Date2018-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04560141947016 K180084 000

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