Cleared Special

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)

K253310 · Esaote, S.P.A. · Radiology
Nov 2025
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K253310 is an FDA 510(k) clearance for the 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30), 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 25, 2025, 57 days after receiving the submission on September 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K253310 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date November 25, 2025
Days to Decision 57 days
Submission Type Special
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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