510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182395Substantially Equivalent

OARtrac System

Radialdyne, LLC, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182395 is the FDA 510(k) clearance record for OARtrac System, a class II device, cleared for Radialdyne, LLC on under FDA product code NZT (Dosimeter, Ionizing Radiation, Implanted). FDA's definition for product code NZT reads: "Verify radiation dose to organs from external radiation therapy". FDA records list one 510(k) clearance for Radialdyne, LLC. As of , FDA records show 5 recalls naming K182395.

Clearance record

Decision date
Received
(199 days to decision)
Product code
NZT Dosimeter, Ionizing Radiation, Implanted
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Radialdyne, LLC 10801 Hammerly Blvd. Suite 220, Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZT

Trailing 12 months

FDA records hold no clearances under product code NZT in the trailing twelve months.

FDA records show no clearances under product code NZT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260