Cleared Traditional

6450 Ultrasound system

K192157 · Esaote, S.P.A. · Radiology
Nov 2019
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K192157 is an FDA 510(k) clearance for the 6450 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 November 22, 2019, 105 days after receiving the submission on August 9, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K192157 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2019
Decision Date November 22, 2019
Days to Decision 105 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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