Cleared Special

7410 Ultrasound System (MyLabSigma)

K191072 · Esaote, S.P.A. · Radiology
Jun 2019
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K191072 is an FDA 510(k) clearance for the 7410 Ultrasound System (MyLabSigma), 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 June 10, 2019, 49 days after receiving the submission on April 22, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K191072 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2019
Decision Date June 10, 2019
Days to Decision 49 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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