Cleared Traditional

QDOSE? Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)

K230221 · Versant Medical Physics and Radiation Safety · Radiology

Aug 2023

Decision

214d

Days

Class 1

Risk

About This 510(k) Submission

K230221 is an FDA 510(k) clearance for the QDOSE? Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy), a Camera, Scintillation (gamma) (Class I — General Controls, product code IYX), submitted by Versant Medical Physics and Radiation Safety (Kalamazoo, US). The FDA issued a Cleared decision on August 28, 2023, 214 days after receiving the submission on January 26, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number	K230221 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 2023
Decision Date	August 28, 2023
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF