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OARtrac System

by Radialdyne, LLC

510(k) K182395

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182395 Date22 Mar 2019ClearedStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NZT
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent