Cleared Traditional

3D-RD-S

K212587 · Radiopharmaceutical Imaging and Dosimetry, LLC · Radiology

Feb 2023

Decision

555d

Days

Class 1

Risk

About This 510(k) Submission

K212587 is an FDA 510(k) clearance for the 3D-RD-S, a Camera, Scintillation (gamma) (Class I — General Controls, product code IYX), submitted by Radiopharmaceutical Imaging and Dosimetry, LLC (Baltimore, US). The FDA issued a Cleared decision on February 22, 2023, 555 days after receiving the submission on August 16, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number	K212587 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2021
Decision Date	February 22, 2023
Days to Decision	555 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF