Cleared Traditional

HS40 Diagnostic Ultrasound System

K221599 · Samsung Medison Co., Ltd. · Radiology
Aug 2022
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K221599 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 August 22, 2022, 81 days after receiving the submission on June 2, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K221599 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2022
Decision Date August 22, 2022
Days to Decision 81 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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