# PathAI, Inc.

- Location (FDA's records): Boston, MA
- FDA decisions: 2 (2022–2025): 2 510(k) clearances
- Product codes: QKQ (2)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems Nederland B.V.: 1 (https://510kreport.com/company/philips-medical-systems-nederland)
- Hamamatsu Photonics K.K.: 1 (https://510kreport.com/company/hamamatsu-photonics)
- Leica Biosystems Imaging, Inc.: 1 (https://510kreport.com/company/leica-biosystems-imaging)

## Recent decisions
- K243391: AISight Dx (Jun 26, 2025)
- K212361: Novo (Aug 11, 2022)

Source page: https://510kreport.com/company/pathai