Clearance Summary
3D-RD-S received FDA 510(k) clearance under submission number K262060, sponsored by Radiopharmaceutical Imaging & Dosimetry, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-09-04.
- Submission: K262060
- Applicant / Sponsor: Radiopharmaceutical Imaging & Dosimetry, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2026-09-04
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.