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510(k) K182395

OARtrac System by Radialdyne, LLC — Product Code NZT

K182395 is an FDA 510(k) premarket notification submitted by Radialdyne, LLC for the device "OARtrac System". The FDA issued a decision of Substantially Equivalent on March 22, 2019. The device falls under product code NZT (Dosimeter, Ionizing Radiation, Implanted), a Class II device regulated under 21 CFR 892.5050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2019
Date Received
September 4, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dosimeter, Ionizing Radiation, Implanted
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Verify radiation dose to organs from external radiation therapy.

Other clearances for product code NZT

  • K250083 — PRO-DOSE System (October 1, 2025)
  • K162954 — OARtrac System with Patient Specific Reusable Universal PSD Sensors (June 1, 2017)
  • K150719 — OARtrac System with Skin Sensors (June 16, 2015)
  • K141154 — OARTRAC SYSTEM (July 22, 2014)
  • K083035 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (November 13, 2008)
  • K080004 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (January 23, 2008)

FDA data resources