Cleared Traditional

K162954 - OARtrac System with Patient Specific Reusable Universal PSD Sensors

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Emergo Group
STUART R. GOLDMAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NZT Dosimeter, Ionizing Radiation, Implanted

Devices cleared under the same product code (NZT) and FDA review panel - the closest regulatory comparables to K162954.
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DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
K080004 · Sicel Technologies, Inc. · Jan 2008
K162954 · OARtrac System with Patient Specific Reusable Universal PSD Sensors
Download PDF FDA Summary Radiadyne, LLC