510(k) · Radiology

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

by Esaote S.p.A.

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) is an AI-enabled medical device from Esaote S.p.A. that the U.S. FDA cleared through 510(k) K241671 on May 16, 2025. Its lead review panel is Radiology and its primary product code is IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK241671
Pathway510(k)
Date of final decision
Company (FDA list)Esaote S.p.A.
Lead review panelRadiology
Primary product codeIYN — System, Imaging, Pulsed Doppler, Ultrasonic
Applicant (openFDA)Esaote, S.p.A.
Applicant locationGenoa, IT
Device classClass 2
Regulation number21 CFR 892.1550
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) went through this pathway (K241671).

openFDA lists it as a Class 2 device under 21 CFR 892.1550. Class II devices are moderate risk and are subject to general and special controls.

Product code IYN covers 124 devices on the FDA AI list. By decision date, this device is #89 of 124 under that code. Esaote S.p.A. has 7 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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