Cleared Traditional

Ultrasound System SONIMAGE HS1

K162065 · Konica Minolta, Inc. · Radiology
Oct 2016
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K162065 is an FDA 510(k) clearance for the Ultrasound System SONIMAGE HS1, 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 October 19, 2016, 85 days after receiving the submission on July 26, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K162065 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2016
Decision Date October 19, 2016
Days to Decision 85 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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