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510(k) K162954

OARtrac System with Patient Specific Reusable Universal PSD Sensors by Radiadyne, LLC — Product Code NZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2017
Date Received
October 24, 2016
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 by Radiadyne, LLC

  • K150719 — OARtrac System with Skin Sensors (June 16, 2015)
  • K141154 — OARTRAC SYSTEM (July 22, 2014)
  • DEN130036 — PROSTATE IMMOBILIZER RECTAL BALLOON (January 28, 2014)
  • K092534 — ALATUS VAGINAL BALLOON PACKING SYSTEM (December 7, 2009)

Other clearances for product code NZT

  • K250083 — PRO-DOSE System (October 1, 2025)
  • K182395 — OARtrac System (March 22, 2019)
  • 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)