FDA 510(k)

レイキャストハイプレシジョン肺ボードソリューション

K番号: K162862 · 2016-11-09

決定日2016-11-09

製品コードIYE

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Substantially Equivalent

医療機器の概要

Raycast High Precision Lung Board Solution is the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2016-11-09 under 510(k) number K162862. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Raycast High Precision Lung Board Solution?

Raycast High Precision Lung Board Solution is a medical device that received FDA 510(k) clearance on 2016-11-09. The listed applicant is Orfit Industries NV. The 510(k) number is K162862.

When did Raycast High Precision Lung Board Solution receive FDA 510(k) clearance?

Raycast High Precision Lung Board Solution received FDA 510(k) clearance on 2016-11-09, under 510(k) number K162862.

Who is the listed applicant for Raycast High Precision Lung Board Solution?

The FDA 510(k) record lists Orfit Industries NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Raycast High Precision Lung Board Solution?

The FDA product code for Raycast High Precision Lung Board Solution is IYE.

申請者としてOrfit Industries NVを記載するその他の記録

K202068The AIO Solution 3.0 K200282オルフィットアエリアルコッチトップ K191158The AIO Solution K171734HP PROポジショニングデバイス K162355レイキャストマモRx カーボンファイバーボストンボード

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