Class Class II
Genius AI Detection 2.0 (K243341)
Description
Genius AI Detection 2.0 by Hologic, Inc., an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243341
Clearance Date2025-07-31
Clearance TypeTraditional
Product CodeQDQ
Regulation Number892.2090
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243341
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Genius AI Detection 2.0 (K243341) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221449 | Genius AI Detection 2.0 | Hologic, Inc. | 2022 |
Trace the full predicate network for K243341
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.