FDA clears 3D-RD-S radiopharmaceutical imaging and dosimetry product

FDA 510(k) clearance for 3D-RD-S, a radiopharmaceutical imaging and dosimetry product from Radiopharmaceutical Imaging & Dosimetry, LLC; product code LLZ, radiology panel review.

• Cleared through the FDA's 510(k) premarket notification pathway under product code LLZ, with review assigned to the agency's radiology device panel.
• Applicant is Radiopharmaceutical Imaging & Dosimetry, LLC; the product name indicates radiopharmaceutical imaging and radiation dosimetry.

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