Cleared Traditional

K230221 - QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) (FDA 510(k) Clearance)

Class I Radiology device.

K230221 · Versant Medical Physics and Radiation Safety · Radiology device
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Aug 2023
Decision
214d
Days
Class 1
Risk

K230221 is an FDA 510(k) clearance for the QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Rad.... Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Versant Medical Physics and Radiation Safety (Kalamazoo, US). The FDA issued a Cleared decision on August 28, 2023 after a review of 214 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Versant Medical Physics and Radiation Safety devices

Submission Details

510(k) Number K230221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 107d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.