Our algorithm correctly identifies actual Predicates used within the top 20 results 80% of the time
Conditioned on the actual Predicate appearing in the top 20, we achieve even greater accuracy - 92% of the time it's in the top 10, and 85% in the top 5
Full Predicate lineage tracking and discovery of other products that use the same Predicates as your subject device.
Facilitate Product Development
Accelerate Regulatory Approval
Enhance Competitive Intelligence
Simply enter a device description to instantly retrieve a comprehensive list of relevant predicates. Uses the same technology that powers ChatGPT to deliver accurate results.
View detailed information about a device, its Predicates, and any sibling devices that make use of the same Predicates. Stay informed on what else is out there on the market.
Use generative AI to compare and analyze predicates side-by-side. Specify any custom criteria based on information from original 510k Summary files released by the FDA.
Turn FDA predicate summaries into your own AI medical device expert. Have confidence in our AI's "context driven" answers with minimal risk for hallucinations.
Never start from scratch when building your 510K Summary reports. Our AI is pre-trained on your chosen Predicate Summaries so you can leave the tedious parts of documentation to the AI and focus on the parts in which you are the expert.