Cleared Traditional

V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System

K240631 · Samsung Medison Co., Ltd. · Radiology
Jun 2024
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K240631 is an FDA 510(k) clearance for the V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 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 June 21, 2024, 107 days after receiving the submission on March 6, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K240631 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2024
Decision Date June 21, 2024
Days to Decision 107 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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