Cleared Special

Ultrasound System SONIMAGE HS1

K182153 · Konica Minolta, Inc. · Radiology
Sep 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K182153 is an FDA 510(k) clearance for the Ultrasound System SONIMAGE HS1, 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 September 6, 2018, 29 days after receiving the submission on August 8, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K182153 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2018
Decision Date September 06, 2018
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement

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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