510(k) K241305

LifeRay Intraoral Handheld X-ray System by Lucas Lifecare — Product Code EHD

K241305 is an FDA 510(k) premarket notification submitted by Lucas Lifecare for the device "LifeRay Intraoral Handheld X-ray System". The FDA issued a decision of Substantially Equivalent on July 5, 2024. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Lucas Lifecare has at least 1 other 510(k) clearance on record.