By SneakyPeakPoints/peopleimages.com on Adobe Stock
PathAI announced the expansion of the AISight Dx digital pathology image management system 510(k) label (K243391) to include the VENTANADP 200 and DP 600 whole slide scanners cleared in 2024 as part of the Roche Digital Pathology Dx medical device (K232879 and K242783).
The label expansion was completed based on the Predetermined Change Control Plan (PCCP) approved as part of the FDA clearance of AISight Dx earlier this month. The PCCP framework, part of FDA’s evolving approach to AI/ML-enabled devices, allows manufacturers to implement pre-specified modifications while maintaining regulatory compliance. By leveraging this pathway, PathAI was able to extend AISight Dx compatibility in a predictable, transparent, and efficient manner—ensuring both safety and performance are maintained as the device adapts to additional platforms. AISight Dx is the first digital pathology image management system (IMS) to secure FDA clearance with an authorized PCCP—joining fewer than 60 PCCP-authorized devices in the entire 510(k) database as of July 2025.
PathAI expects to announce further expansion of the AISight Dx label for primary diagnosis with additional slide image scanners and monitors in the coming months.
