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Informational only. Not affiliated with any government agency. Verify details at the official source.

Devices

BrightHeart

4 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.

DateSubmissionDevicePanelCode
June 5, 2025K251456BrightHeart View ClassifierRadiologyQIH
May 7, 2025K243684BrightHeart View ClassifierRadiologyQIH
May 2, 2025K251071Fetal EchoScan (v1.1)RadiologyPOK
November 14, 2024K242342Fetal EchoScanRadiologyPOK