Class Class II
AISight Dx (K243391)
Description
AISight Dx by PathAI, Inc., an FDA 510(k) cleared pathology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243391
Clearance Date2025-06-26
Clearance TypeTraditional
Product CodeQKQ
Regulation Number864.3700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243391
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. AISight Dx (K243391) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232202 | Aperio GT 450 DX | Leica Biosystems Imaging, Inc. | 2024 |
| K233027 | NanoZoomer S360MD Slide scanner system | Hamamatsu Photonics K.K. | 2023 |
Trace the full predicate network for K243391
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.