FDA 510(k)

SANGRAY

K 號：K172087 · 2017-10-27

決定日期2017-10-27

產品代碼MOT

決定相當於

器材摘要

SANGRAY is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K172087. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

常見問題

What is the SANGRAY?

SANGRAY is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Hitachi , Ltd.. The 510(k) number is K172087.

When did SANGRAY receive FDA 510(k) clearance?

SANGRAY received FDA 510(k) clearance on 2017-10-27, under 510(k) number K172087.

Who is the listed applicant for SANGRAY?

The FDA 510(k) record lists Hitachi , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANGRAY?

The FDA product code for SANGRAY is MOT.

其他以 Hitachi , Ltd. 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。

K201042PROBEAT-CR K191801PROBEAT-CR K163505ARIETTA PRECISION K162902ARIETTA Prologue 诊断超声系统及探头 K162583ALOKA LISENDO 880 K161163PROBEAT-V 質子束治療系統搭配X光限制配件

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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 K161324瑞塞爾Mk2Best Theratronics Limited

官方來源

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