FDA 510(k)

雷射高精準肺板解決方案

K 號：K162862 · 2016-11-09

決定日期2016-11-09

產品代碼IYE

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Orfit Industries NV 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：IYE）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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