Transparency Registry · applicant
Caption Health: 4 FDA AI clearances
Every 510(k) clearance held by Caption Health under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.
| Device | Decision date | Category |
|---|---|---|
| Caption Interpretation Automated Ejection Fraction Software | 2022-01-19 | QIH |
| Caption Guidance | 2020-09-18 | QJU |
| Caption Interpretation Automated Ejection Fraction Software | 2020-07-22 | QIH |
| Caption Guidance | 2020-04-16 | QJU |
Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Caption Health? The disclosure rows on your entries update free on submission of public links — start here.
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