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FDA 510(k)

Fetal EchoScan (v1.1)

K-Number: K251071 · 2025-05-02

ApplicantBrightheart
Decision Date2025-05-02
Product CodePOK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Fetal EchoScan (v1.1) is the device name listed in this FDA 510(k) record. The listed applicant is Brightheart. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K251071. The device is classified under product code POK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fetal EchoScan (v1.1)?

Fetal EchoScan (v1.1) is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Brightheart. The 510(k) number is K251071.

When did Fetal EchoScan (v1.1) receive FDA 510(k) clearance?

Fetal EchoScan (v1.1) received FDA 510(k) clearance on 2025-05-02, under 510(k) number K251071.

Who is the listed applicant for Fetal EchoScan (v1.1)?

The FDA 510(k) record lists Brightheart as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fetal EchoScan (v1.1)?

The FDA product code for Fetal EchoScan (v1.1) is POK.

Other records listing Brightheart as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252294Fetal EchoScan (v1.2)K251456BrightHeart View ClassifierK243684BrightHeart View ClassifierK242342Fetal EchoScan

Related Devices (Code: POK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253884Koios DS (3.8)Koios Medical, Inc.K261519Sonio SuspectSonioK254161Automated Aortic Stenosis Software (AutoAS)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK251769RevealAI-LungPrecision Medical Ventures, Inc. Dba RevealdxK252294Fetal EchoScan (v1.2)BrightheartK250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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