Cleared Traditional

6440 MyLabX90

K230179 · Esaote, S.P.A. · Radiology
Nov 2023
Decision
310d
Days
Class 2
Risk

About This 510(k) Submission

K230179 is an FDA 510(k) clearance for the 6440 MyLabX90, 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 29, 2023, 310 days after receiving the submission on January 23, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K230179 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2023
Decision Date November 29, 2023
Days to Decision 310 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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