510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141154Substantially Equivalent

Oartrac System

Radiadyne, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141154 is the FDA 510(k) clearance record for OARTRAC SYSTEM, a class II device, cleared for Radiadyne 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 5 510(k) clearances for Radiadyne, from to . As of , FDA records show no recalls naming K141154.

Clearance record

Decision date
Received
(78 days to decision)
Product code
NZT Dosimeter, Ionizing Radiation, Implanted
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Radiadyne 816 Congress Ave. Suite 1400, Austin 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