Fetal EchoScan (v1.2)
FDA 510(k)Class II (US FDA 510(k))
by Brightheart
Identifiers
- 510(k) Number
- K252294 FDA 510(k)
- FDA Product Code
- POK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2060 FDA 510(k)
- Regulation Number
- 892.2060 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fetal EchoScan (v1.2) is a machine learning-based computer-assisted diagnosis software device. It functions as an adjunct to fetal heart ultrasound examinations in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams between 18 and 24 weeks of gestational age.
The software analyzes cardiac fetal ultrasound video clips to assist in the interpretation of diagnostic imaging. This device has received US FDA marketing authorization under submission K252294.
Frequently asked questions
What is the intended use of the Fetal EchoScan (v1.2)?
This software is designed as an adjunct to fetal heart ultrasound examinations. It uses machine learning to assist clinicians in the interpretation of diagnostic imaging during second-trimester anatomic ultrasound exams.
Which patient population is this software intended for?
The device is intended for use in pregnant women aged 18 or older who are undergoing second-trimester anatomic ultrasound examinations between 18 and 24 weeks of gestational age.
What is the regulatory status of this device?
The Fetal EchoScan (v1.2) has received US FDA marketing authorization under submission number K252294, following a traditional 510(k) review process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BrightHeart, Fetal EchoScan (v1.2) Review: Pricing, FDA Status & Alternatives ..., Brightheart: Fetal EchoScan (v1.2) (FDA-cleared AI medical device)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252294 | Class II | Active |
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Manufacturer
- Manufacturer
- Brightheart
Sources (1)
- FDA 510(k) K252294 24 fields · synced Sep 21, 2026