Transparency Registry · applicant
Hologic, Inc.: 4 FDA AI clearances
Every 510(k) clearance held by Hologic, Inc. 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 |
|---|---|---|
| Genius AI Detection 2.0 | 2025-07-31 | QDQ |
| Genius AI Detection 2.0 with CC-MLO Correlation | 2023-05-23 | QDQ |
| Genius AI Detection 2.0 | 2022-10-06 | QDQ |
| Genius AI Detection | 2020-11-18 | QDQ |
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 Hologic, Inc.? The disclosure rows on your entries update free on submission of public links — start here.
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