Cleared Traditional

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

K241671 · Esaote, S.P.A. · Radiology
May 2025
Decision
339d
Days
Class 2
Risk

About This 510(k) Submission

K241671 is an FDA 510(k) clearance for the 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85), 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 16, 2025, 339 days after receiving the submission on June 11, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K241671 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 2024
Decision Date May 16, 2025
Days to Decision 339 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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