510(k) · Radiology

Fetal EchoScan (v1.1)

by BrightHeart

Fetal EchoScan (v1.1) is an AI-enabled medical device from BrightHeart that the U.S. FDA cleared through 510(k) K251071 on May 2, 2025. Its lead review panel is Radiology and its primary product code is POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

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

Key facts

Submission numberK251071
Pathway510(k)
Date of final decision
Company (FDA list)BrightHeart
Lead review panelRadiology
Primary product codePOK — Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Applicant (openFDA)Brightheart
Applicant locationParis, FR
Device classClass 2
Regulation number21 CFR 892.2060
Decision codeSESE
Submission typeSpecial

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. Fetal EchoScan (v1.1) went through this pathway (K251071).

openFDA lists it as a Class 2 device under 21 CFR 892.2060. Class II devices are moderate risk and are subject to general and special controls.

Product code POK covers 22 devices on the FDA AI list. By decision date, this device is #17 of 22 under that code. BrightHeart has 5 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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