FDA-cleared K252294
Fetal EchoScan (v1.2)
Brightheart
Concurrent CADx aid for suspicious fetal cardiac morphological findings during second-trimester fetal heart ultrasound.
- Modality
- Ultrasound
- Anatomy
- Fetal Heart / Obstetric
- Decision
- 2025-12-08
Vendor
Brightheart
5 FDA-cleared listings in this directory.
Claim vendor profile FDA-cleared K251456
BrightHeart View Classifier
BrightHeart
Automatic standard-view classification, frame extraction, and acquisition-protocol assessment during second- or third-trimester fetal ultrasound.
- Modality
- Ultrasound
- Anatomy
- Fetal heart and abdomen standard views during fetal anatomic ultrasound
- Decision
- 2025-06-05
FDA-cleared K243684
BrightHeart View Classifier
BrightHeart
Automatic standard-view detection and frame extraction to support acquisition and interpretation of second- or third-trimester fetal heart ultrasound.
- Modality
- Ultrasound
- Anatomy
- Obstetric/Fetal
- Decision
- 2025-05-07
FDA-cleared K251071
Fetal EchoScan (v1.1)
BrightHeart
Adjunctive detection of suspicious fetal cardiac findings during second-trimester ultrasound to aid concurrent OB-GYN or maternal-fetal-medicine interpretation.
- Modality
- Ultrasound
- Anatomy
- Fetal heart, including four-chamber, left-ventricular-outflow-tract, and right-ventricular-outflow-tract views and the specified suspicious cardiac findings
- Decision
- 2025-05-02
FDA-cleared K242342
Fetal EchoScan
BrightHeart
Adjunctive CADx aid for interpreting OB-GYN/MFM physicians to identify suspicious fetal-cardiac findings in second-trimester anatomic ultrasound that may suggest congenital heart...
- Modality
- Ultrasound
- Anatomy
- Fetal heart, including the cardiac crux, outflow tracts, cardiac axis, ventricles, and valve annular relationships.
- Decision
- 2024-11-14