Company ยท US
Caption Health
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 15, 2025 | K243065 | Cardiac Guidance Caption Health, Inc. | QJU |
| Feb 24, 2023 | DEN220063 | Caption Interpretation Automated Ejection Fraction Software Caption Health, Inc. | QVD |
| Jan 19, 2022 | K210747 | Caption Interpretation Automated Ejection Fraction Software Caption Health | QIH |
| Sep 18, 2020 | K201992 | Caption Guidance Caption Health | QJU |
| Jul 22, 2020 | K200621 | Caption Interpretation Automated Ejection Fraction Software Caption Health | QIH |
| Apr 16, 2020 | K200755 | Caption Guidance Caption Health | QJU |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2021 | Caption Health Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0) Terminated |
QIH | K200621 |