Caption Health
FDA Regulatory Profile
Caption Health appears in FDA public data with 1 recall, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2111-2021, Class II) was initiated on May 19, 2021. Its most recent 510(k) clearance was granted on January 15, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2111-2021 | Class II | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application So | May 19, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243065 | Cardiac Guidance | January 15, 2025 |
| DEN220063 | Caption Interpretation Automated Ejection Fraction Software | February 24, 2023 |
| K210747 | Caption Interpretation Automated Ejection Fraction Software | January 19, 2022 |
| K201992 | Caption Guidance | September 18, 2020 |
| K200621 | Caption Interpretation Automated Ejection Fraction Software | July 22, 2020 |
| K200755 | Caption Guidance | April 16, 2020 |