510(k) K262060

3D-RD-S by Radiopharmaceutical Imaging & Dosimetry, LLC — Product Code LLZ

K262060 is an FDA 510(k) premarket notification submitted by Radiopharmaceutical Imaging & Dosimetry, LLC for the device "3D-RD-S". The FDA issued a decision of Substantially Equivalent on September 4, 2026. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Radiopharmaceutical Imaging & Dosimetry, LLC has at least 1 other 510(k) clearance on record.