Caption Health
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of GE HealthCareLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 6 spellings of its name, each linked to the record.
- AI-enabled devices: 6
- 510(k) clearances: 5
- Device recalls: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jan 15, 2025 | Cardiac GuidanceK243065 · QJU | 510(k) clearances |
| Jan 15, 2025 | Cardiac GuidanceK243065 · Radiology | AI-enabled devices |
| Feb 24, 2023 | Caption Interpretation Automated Ejection Fraction SoftwareDEN220063 · QVD | 510(k) clearances |
| Feb 24, 2023 | Caption Interpretation Automated Ejection Fraction SoftwareDEN220063 · Radiology | AI-enabled devices |
| Jan 19, 2022 | Caption Interpretation Automated Ejection Fraction SoftwareK210747 · QIH | 510(k) clearances |
| Jan 19, 2022 | Caption Interpretation Automated Ejection Fraction SoftwareK210747 · Radiology | AI-enabled devices |
| May 19, 2021 | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)008600035Class II · The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This co | Device recalls |
| Sep 18, 2020 | Caption GuidanceK201992 · QJU | 510(k) clearances |
| Sep 18, 2020 | Caption GuidanceK201992 · Radiology | AI-enabled devices |
| Jul 22, 2020 | Caption Interpretation Automated Ejection Fraction SoftwareK200621 · QIH | 510(k) clearances |
| Jul 22, 2020 | Caption Interpretation Automated Ejection Fraction SoftwareK200621 · Radiology | AI-enabled devices |
| Apr 16, 2020 | Caption GuidanceK200755 · QJU | 510(k) clearances |
| Apr 16, 2020 | Caption GuidanceK200755 · Radiology | AI-enabled devices |
Names and Identifiers
- Appears as
- Website
- gehealthcare.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built