Cleared Special

6400 Ultrasound System (MyLabX6, MyLabX7)

K190989 · Esaote, S.P.A. · Radiology
May 2019
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K190989 is an FDA 510(k) clearance for the 6400 Ultrasound System (MyLabX6, MyLabX7), 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 May 10, 2019, 25 days after receiving the submission on April 15, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K190989 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2019
Decision Date May 10, 2019
Days to Decision 25 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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