Cleared Traditional

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

K230084 · Samsung Medison Co., Ltd. · Radiology
Apr 2023
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K230084 is an FDA 510(k) clearance for the HERA W10 Diagnostic Ultrasound System; HERA W9 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 21, 2023, 100 days after receiving the submission on January 11, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K230084 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2023
Decision Date April 21, 2023
Days to Decision 100 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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