FDA 510(k)

3D-RD-S

K-Number: K262060 · 2026-09-04

ApplicantRadiopharmaceutical Imaging & Dosimetry, LLC

Decision Date2026-09-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3D-RD-S is the device name listed in this FDA 510(k) record. The listed applicant is Radiopharmaceutical Imaging & Dosimetry, LLC. It received FDA 510(k) clearance on 2026-09-04 under 510(k) number K262060. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D-RD-S?

3D-RD-S is a medical device that received FDA 510(k) clearance on 2026-09-04. The listed applicant is Radiopharmaceutical Imaging & Dosimetry, LLC. The 510(k) number is K262060.

When did 3D-RD-S receive FDA 510(k) clearance?

3D-RD-S received FDA 510(k) clearance on 2026-09-04, under 510(k) number K262060.

Who is the listed applicant for 3D-RD-S?

The FDA 510(k) record lists Radiopharmaceutical Imaging & Dosimetry, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D-RD-S?

The FDA product code for 3D-RD-S is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261500KBA3D (v2.4.0)S.M.A.I.O K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.