Cleared Traditional

6440 Ultrasound System

K173291 · Esaote, S.P.A. · Radiology
Jan 2018
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K173291 is an FDA 510(k) clearance for the 6440 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 January 12, 2018, 88 days after receiving the submission on October 16, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K173291 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2017
Decision Date January 12, 2018
Days to Decision 88 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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