Cleared Traditional

Ultrasound System SONIMAGE MX1

K220993 · Konica Minolta, Inc. · Radiology
Jun 2022
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K220993 is an FDA 510(k) clearance for the Ultrasound System SONIMAGE MX1, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Konica Minolta, Inc. (Hino-Shi, JP). The FDA issued a Cleared decision on June 23, 2022, 80 days after receiving the submission on April 4, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K220993 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2022
Decision Date June 23, 2022
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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