Cleared Special

6420 Ultrasound System

K183191 · Esaote, S.P.A. · Radiology
Dec 2018
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K183191 is an FDA 510(k) clearance for the 6420 Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Esaote, S.P.A. (Genoa, IT). The FDA issued a Cleared decision on December 4, 2018, 15 days after receiving the submission on November 19, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K183191 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2018
Decision Date December 04, 2018
Days to Decision 15 days
Submission Type Special
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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