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Brightheart

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252294Fetal EchoScan (v1.2)December 8, 2025
K251456BrightHeart View ClassifierJune 5, 2025
K243684BrightHeart View ClassifierMay 7, 2025
K251071Fetal EchoScan (v1.1)May 2, 2025
K242342Fetal EchoScanNovember 14, 2024