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510(k) K141154

OARTRAC SYSTEM by Radiadyne — Product Code NZT

K141154 is an FDA 510(k) premarket notification submitted by Radiadyne for the device "OARTRAC SYSTEM". The FDA issued a decision of Substantially Equivalent on July 22, 2014. The device falls under product code NZT (Dosimeter, Ionizing Radiation, Implanted), a Class II device regulated under 21 CFR 892.5050. Radiadyne has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2014
Date Received
May 5, 2014
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

  • K162954 — OARtrac System with Patient Specific Reusable Universal PSD Sensors (June 1, 2017)
  • K150719 — OARtrac System with Skin Sensors (June 16, 2015)
  • 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)
  • K162954 — OARtrac System with Patient Specific Reusable Universal PSD Sensors (June 1, 2017)
  • K150719 — OARtrac System with Skin Sensors (June 16, 2015)
  • K083035 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (November 13, 2008)
  • K080004 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (January 23, 2008)

FDA data resources