OARTRAC SYSTEM— 510(k) K141154

Substantially Equivalent

Radiadyne

FDA 510(k) clearance K141154 for OARTRAC SYSTEM, Substantially Equivalent on 2014-07-22. Applicant: Radiadyne. Device class: 2.

Clearance details

Applicant: Radiadyne
Product code: Code NZT
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2014-05-05
Decision date: 2014-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.