Cleared Traditional

V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System

K220975 · Samsung Medison Co., Ltd. · Radiology
Jun 2022
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K220975 is an FDA 510(k) clearance for the V8 Diagnostic Ultrasound System, V7 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 29, 2022, 86 days after receiving the submission on April 4, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K220975 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2022
Decision Date June 29, 2022
Days to Decision 86 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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