Cleared Traditional

K182395 - OARtrac System (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182395 · Radialdyne, LLC · Radiology device
Mar 2019
Decision
199d
Days
Class 2
Risk

K182395 is an FDA 510(k) clearance for the OARtrac System. Classified as Dosimeter, Ionizing Radiation, Implanted (product code NZT), Class II - Special Controls.

Submitted by Radialdyne, LLC (Houston, US). The FDA issued a Cleared decision on March 22, 2019 after a review of 199 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.

Submission Details

510(k) Number K182395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date March 22, 2019
Days to Decision 199 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 128d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.