Cleared Special

Fetal EchoScan (v1.1)

K251071 · Brightheart · Radiology

May 2025

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K251071 is an FDA 510(k) clearance for the Fetal EchoScan (v1.1), a Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code POK), submitted by Brightheart (Paris, FR). The FDA issued a Cleared decision on May 2, 2025, 25 days after receiving the submission on April 7, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2060.

Submission Details

510(k) Number	K251071 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 07, 2025
Decision Date	May 02, 2025
Days to Decision	25 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	POK — Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2060
Definition	Assist Users In Characterizing Lesions Identified On Acquired Medical Images