Cleared Traditional

K230221 - QDOSE Multi-purpose Voxel Dosimetry (Pe...

K230221 is an FDA 510(k) clearance for QDOSE Multi-purpose Voxel Dosimetry (Pe..., manufactured by Versant Medical Physics and Radiation Safety. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K230221 · Versant Medical Physics and Radiation Safety · Radiology device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K230221

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.

IYX Device Classification - Class 1, General Controls

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.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 64
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