Cleared Traditional

Ultrasound System SONIMAGE HS1

K151060 · Konica Minolta, Inc. · Radiology
Jun 2015
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K151060 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 June 5, 2015, 46 days after receiving the submission on April 20, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K151060 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2015
Decision Date June 05, 2015
Days to Decision 46 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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