Cleared Traditional

K162954 - OARtrac System with Patient Specific Re...

K162954 is an FDA 510(k) clearance for OARtrac System with Patient Specific Re..., manufactured by Radiadyne, LLC. The device is a Class 2 Radiology device with product code NZT cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K162954 · Radiadyne, LLC · Radiology device
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Jun 2017
Decision
220d
Days
Class 2
Risk

K162954 is an FDA 510(k) clearance for the OARtrac System with Patient Specific Reusable Universal PSD Sensors. Classified as Dosimeter, Ionizing Radiation, Implanted (product code NZT), Class II - Special Controls.

Submitted by Radiadyne, LLC (Houston, US). The FDA issued a Cleared decision on June 1, 2017 after a review of 220 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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.

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FDA 510(k) Submission Details - K162954

510(k) Number K162954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date June 01, 2017
Days to Decision 220 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 107d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NZT Device Classification - Class 2, Special Controls

Product Code NZT Dosimeter, Ionizing Radiation, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
Definition Verify Radiation Dose To Organs From External Radiation Therapy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.