FDA 510(k)

OARtrac システムおよび患者特別な再利用可能なユニバーサル PSDセンサー

K番号: K162954 · 2017-06-01

決定日2017-06-01

製品コードNZT

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

OARtrac System with Patient Specific Reusable Universal PSD Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Radiadyne, LLC. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K162954. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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.

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OARtrac システムおよび患者特別な再利用可能なユニバーサル PSDセンサー

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：NZT）

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