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OARtrac OT-CDU2P

by Radiadyne, L.L.C.

OARtrac OT-CDU2P is a MOSFET radiation therapy dosimetry system (FDA Class II; FDA product code NZT, Dosimeter, Ionizing Radiation, Implanted) made by Radiadyne, L.L.C., cleared under FDA 510(k) K182395 on 22 Mar 2019 and listed in FDA GUDID since 3 Jul 2019 (UDI-DI 00851546007196), active as of 22 Oct 2026. 5 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

510(k) K182395

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851546007196 UDI-DI Date3 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182395 Date22 Mar 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182395 decided 22 Mar 2019 Active
  • FDA GUDID UDI-DI 00851546007196 listed 3 Jul 2019 Listed

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0709-2020 FDA Class II initiated 19 Nov 2019
    • Terminated Z-0712-2020 FDA Class II initiated 19 Nov 2019
    • Terminated Z-0713-2020 FDA Class II initiated 19 Nov 2019
    • Terminated Z-0711-2020 FDA Class II initiated 19 Nov 2019
    • Terminated Z-0710-2020 FDA Class II initiated 19 Nov 2019

    May result in readings outside of the expected accuracy range.

Timeline

7 dated events

  1. Cleared FDA 510(k) K182395
  2. Listed FDA GUDID 00851546007196
  3. Recall initiated FDA recalls Z-0709-2020
  4. Recall initiated FDA recalls Z-0712-2020
  5. Recall initiated FDA recalls Z-0713-2020
  6. Recall initiated FDA recalls Z-0711-2020
  7. Recall initiated FDA recalls Z-0710-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OARtrac
Generic name
MOSFET radiation therapy dosimetry system
Model / Ref / Catalog
OT-CDU2P
Primary DI / UDI-DI
00851546007196
510(k) Number
FDA product code
NZT
GMDN term
MOSFET radiation therapy dosimetry system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: MOSFET radiation therapy dosimetry system

Similar devices

Other devices filed under FDA product code NZT (Dosimeter, Ionizing Radiation, Implanted).

Other devices from Radiadyne, L.L.C.

See all devices from Radiadyne, L.L.C. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)