Cleared Special

K251071 - Fetal EchoScan (v1.1) (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251071 · Brightheart · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
25d
Days
Class 2
Risk

K251071 is an FDA 510(k) clearance for the Fetal EchoScan (v1.1). Classified as Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK), Class II - Special Controls.

Submitted by Brightheart (Paris, FR). The FDA issued a Cleared decision on May 2, 2025 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2060 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Brightheart devices

Submission Details

510(k) Number K251071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

All 20
Devices cleared under the same product code (POK) and FDA review panel - the closest regulatory comparables to K251071.
Automated Aortic Stenosis Software (AutoAS)
K254161 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Mar 2026
RevealAI-Lung
K251769 · Precision Medical Ventures, Inc. Dba Revealdx · Jan 2026
Fetal EchoScan (v1.2)
K252294 · Brightheart · Dec 2025
StrokeSENS ASPECTS Software Application
K250221 · Circle Cardiovascular Imaging, Inc. · Jul 2025
Sonio Suspect
K243614 · Sonio · Feb 2025
Brainomix 360 e-ASPECTS
K243294 · Brainomix Limited · Feb 2025