FDA cleared the 3D-RD-S from Radiopharmaceutical Imaging & Dosimetry, LLC on Sep 4, 2026 under K262060, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.
FDA logged the submission as received on Jun 18, 2026. The decision came 78 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for Radiopharmaceutical Imaging & Dosimetry, LLC in the last 12 months of the tracker.