Cleared Traditional

HM70 EVO Diagnostic Ultrasound System

K233112 · Samsung Medison Co., Ltd. · Radiology
Dec 2023
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K233112 is an FDA 510(k) clearance for the HM70 EVO 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 December 21, 2023, 85 days after receiving the submission on September 27, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K233112 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date December 21, 2023
Days to Decision 85 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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