Cleared Traditional

6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

K243253 · Esaote, S.P.A. · Radiology
Jun 2025
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K243253 is an FDA 510(k) clearance for the 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70), 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 18, 2025, 246 days after receiving the submission on October 15, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K243253 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2024
Decision Date June 18, 2025
Days to Decision 246 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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