Cleared Traditional

6200 Ultrasound System and 6250 Ultrasound System

K163082 · Esaote, S.P.A. · Radiology
Mar 2017
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K163082 is an FDA 510(k) clearance for the 6200 Ultrasound System and 6250 Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Esaote, S.P.A. (Genova, IT). The FDA issued a Cleared decision on March 16, 2017, 133 days after receiving the submission on November 3, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K163082 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2016
Decision Date March 16, 2017
Days to Decision 133 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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