510(k) clearance

3D-RD-S

FDA 510(k) source

510(k) number

K262060

Applicant

Radiopharmaceutical Imaging & Dosimetry, LLC

Decision date

Sep 4, 2026

Date received

Jun 18, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

LLZ

Device type

System, Image Processing, Radiological

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Baltimore, MD, US