FDA 510(k)

瑞塞爾Mk2

K 號：K161324 · 2016-08-12

決定日期2016-08-12

產品代碼MOT

決定相當於

器材摘要

Raycell Mk2 is the device name listed in this FDA 510(k) record. The listed applicant is Best Theratronics Limited. It received FDA 510(k) clearance on 2016-08-12 under 510(k) number K161324. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

常見問題

What is the Raycell Mk2?

Raycell Mk2 is a medical device that received FDA 510(k) clearance on 2016-08-12. The listed applicant is Best Theratronics Limited. The 510(k) number is K161324.

When did Raycell Mk2 receive FDA 510(k) clearance?

Raycell Mk2 received FDA 510(k) clearance on 2016-08-12, under 510(k) number K161324.

Who is the listed applicant for Raycell Mk2?

The FDA 510(k) record lists Best Theratronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Raycell Mk2?

The FDA product code for Raycell Mk2 is MOT.

其他以 Best Theratronics Limited 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。

K181737瑞塞爾 MK1

相關器械（代碼：MOT）

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。

K201177RadGil2R3 X-Ray L.L.C K181737瑞塞爾 MK1Best Theratronics Limited K172087SANGRAYHitachi , Ltd.

官方來源

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