K243391
- 510(k) number
- K243391
- Device name
- AISight Dx
- Applicant
- PathAI, Inc. MA · US
- Product code
- QKQ — Digital Pathology Image Viewing And Management Softw
- Decision date
- 2025-06-26
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243391.pdf
Official FDA record: K243391
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.