Cleared Traditional

Ultrasound System SONIMAGE MX1

K180084 · Konica Minolta, Inc. · Radiology
Feb 2018
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K180084 is an FDA 510(k) clearance for the Ultrasound System SONIMAGE MX1, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Konica Minolta, Inc. (Hino-Shi, JP). The FDA issued a Cleared decision on February 8, 2018, 28 days after receiving the submission on January 11, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K180084 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2018
Decision Date February 08, 2018
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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