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FDA 510(k)

OARtrac System

K-Number: K182395 · 2019-03-22

ApplicantRadialdyne, LLC
Decision Date2019-03-22
Product CodeNZT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OARtrac System is the device name listed in this FDA 510(k) record. The listed applicant is Radialdyne, LLC. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K182395. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OARtrac System?

OARtrac System is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Radialdyne, LLC. The 510(k) number is K182395.

When did OARtrac System receive FDA 510(k) clearance?

OARtrac System received FDA 510(k) clearance on 2019-03-22, under 510(k) number K182395.

Who is the listed applicant for OARtrac System?

The FDA 510(k) record lists Radialdyne, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OARtrac System?

The FDA product code for OARtrac System is NZT.

Related Devices (Code: NZT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250083PRO-DOSE SystemNu-Rise, SAK162954OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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