FDA-cleared K200755
Caption Guidance
Caption Health
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-04-16
Vendor
Caption Health
4 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K200621
Caption Interpretation Automated Ejection Fraction Software
Caption Health
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2020-07-22
FDA-cleared K201992
Caption Guidance
Caption Health
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2020-09-18
FDA-cleared K210747
Caption Interpretation Automated Ejection Fraction Software
Caption Health
Image analysis/processing.
- Modality
- Ultrasound
- Anatomy
- N/A
- Decision
- 2022-01-19