Cleared Traditional

HS40 Diagnostic Ultrasound System

K210426 · Samsung Medison Co., Ltd. · Radiology
May 2021
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K210426 is an FDA 510(k) clearance for the HS40 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 May 13, 2021, 91 days after receiving the submission on February 11, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K210426 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2021
Decision Date May 13, 2021
Days to Decision 91 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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