Cleared Traditional

RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System

K221117 · Samsung Medison Co., Ltd. · Radiology
Jun 2022
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K221117 is an FDA 510(k) clearance for the RS85 Diagnostic Ultrasound System, RS80 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 June 17, 2022, 60 days after receiving the submission on April 18, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K221117 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2022
Decision Date June 17, 2022
Days to Decision 60 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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