510(k) K242161

Radlink GPS Pro Imaging by Radlink, Inc. — Product Code LLZ

K242161 is an FDA 510(k) premarket notification submitted by Radlink, Inc. for the device "Radlink GPS Pro Imaging". The FDA issued a decision of Substantially Equivalent on March 18, 2025. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Radlink, Inc. has at least 1 other 510(k) clearance on record.