OARtrac System with Patient Specific Reusable Universal PSD Sensors
K-Number: K162954 · 2017-06-01
Device Summary
Frequently Asked Questions
What is the OARtrac System with Patient Specific Reusable Universal PSD Sensors?
OARtrac System with Patient Specific Reusable Universal PSD Sensors is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Radiadyne, LLC. The 510(k) number is K162954.
When did OARtrac System with Patient Specific Reusable Universal PSD Sensors receive FDA 510(k) clearance?
OARtrac System with Patient Specific Reusable Universal PSD Sensors received FDA 510(k) clearance on 2017-06-01, under 510(k) number K162954.
Who is the listed applicant for OARtrac System with Patient Specific Reusable Universal PSD Sensors?
The FDA 510(k) record lists Radiadyne, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors?
The FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors is NZT.
Related Clinical Trials
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.
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.
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.