Cleared Special

ULTRASOUND SYSTEM SONIMAGE HS 1

K152577 · Konica Minolta, Inc. · Radiology
Oct 2015
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K152577 is an FDA 510(k) clearance for the ULTRASOUND SYSTEM SONIMAGE HS 1, 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 8, 2015, 29 days after receiving the submission on September 9, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K152577 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2015
Decision Date October 08, 2015
Days to Decision 29 days
Submission Type Special
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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