OARtrac System with Patient Specific Reusable Universal PSD Sensors— 510(k) K162954

Name: FDA 510(k) clearance K162954
Creator: U.S. Food and Drug Administration
Published: 2017-06-01

Substantially Equivalent

Radiadyne, LLC

FDA 510(k) clearance K162954 for OARtrac System with Patient Specific Reusable Universal PSD Sensors, Substantially Equivalent on 2017-06-01. Applicant: Radiadyne, LLC. Device class: 2.

Clearance details

Applicant: Radiadyne, LLC
Product code: Code NZT
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2016-10-24
Decision date: 2017-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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