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B-Right Views Fetal Heart
BRIGHTHEART · Model V1.x · UDI-DI 03760415600031
QIH
Prescription
1
510(k) clearances
10
Adverse events
2
Recalls
243
Facilities
Description
BrightHeart View Classifier is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound examinations.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-07 | PIE Medical Imaging B.V. | User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d |
| 2021-05-19 | Caption Health | The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoE |
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