Cleared Traditional

V8 Diagnostic Ultrasound System

K211945 · Samsung Medison Co., Ltd. · Radiology
Sep 2021
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K211945 is an FDA 510(k) clearance for the V8 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 September 8, 2021, 77 days after receiving the submission on June 23, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K211945 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2021
Decision Date September 08, 2021
Days to Decision 77 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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