FDA-cleared K242342
Fetal EchoScan
BrightHeart
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2024-11-14
Vendor
BrightHeart
5 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K251071
Fetal EchoScan (v1.1)
BrightHeart
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-05-02
FDA-cleared K243684
BrightHeart View Classifier
BrightHeart
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-05-07
FDA-cleared K251456
BrightHeart View Classifier
BrightHeart
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2025-06-05
FDA-cleared K252294
Fetal EchoScan (v1.2)
Brightheart
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2025-12-08