Cleared Traditional

HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System

K210068 · Samsung Medison Co., Ltd. · Radiology
Apr 2021
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K210068 is an FDA 510(k) clearance for the HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Samsung Medison Co., Ltd. (Hongcheon-Gun, KR). The FDA issued a Cleared decision on April 9, 2021, 88 days after receiving the submission on January 11, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K210068 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2021
Decision Date April 09, 2021
Days to Decision 88 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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