Transparency Registry · applicant
HeartLung Corporation: 2 FDA AI clearances
Every 510(k) clearance held by HeartLung Corporation 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 |
|---|---|---|
| AI-CVD | 2025-12-19 | QIH |
| AutoChamber | 2024-10-10 | QIH |
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 HeartLung Corporation? The disclosure rows on your entries update free on submission of public links — start here.
Link to this page. Many companies reference
their registry listing from press pages and footers — it is a neutral,
weekly-verified public record. Copy either snippet:
Text link:
Badge: