Cantronic Systems Inc. Warning Letter Details

Summary

Cantronic Systems Inc. was cited for offering multiple thermal imaging temperature scanner devices (FeverScan and LGC300 models) for sale in the United States without required FDA marketing approval, clearance, or authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to obtain premarket approval (PMA) or investigational device exemption (IDE) authorization and did not submit the required 510(k) notification to FDA before introducing these devices into interstate commerce. These violations rendered the products both adulterated and misbranded under federal law, and their introduction or delivery for introduction into interstate commerce was prohibited.