FDA 510(k)

日立Supria全身X光CT系統第3階段

K 號：K163528 · 2017-03-03

申請人Hitachi Medical Systems America, Inc.

決定日期2017-03-03

產品代碼JAK

諮詢委員會RA

決定相當於

器材摘要

HITACHI Supria Whole-body X-ray CT System Phase 3 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K163528. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HITACHI Supria Whole-body X-ray CT System Phase 3?

HITACHI Supria Whole-body X-ray CT System Phase 3 is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K163528.

When did HITACHI Supria Whole-body X-ray CT System Phase 3 receive FDA 510(k) clearance?

HITACHI Supria Whole-body X-ray CT System Phase 3 received FDA 510(k) clearance on 2017-03-03, under 510(k) number K163528.

Who is the listed applicant for HITACHI Supria Whole-body X-ray CT System Phase 3?

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

What is the FDA product code for HITACHI Supria Whole-body X-ray CT System Phase 3?

The FDA product code for HITACHI Supria Whole-body X-ray CT System Phase 3 is JAK.

其他以 Hitachi Medical Systems America, Inc. 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。

K162079三麗珠橢圓頭線圈 32 K161748SUPRIA 配置導向選項 K160152翠麗姆卵形V 5.1 MRI系統 K153547ECHELON 橢圓 V 5.1 MRI 系統

相關器械（代碼：JAK）

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。

K261125BodyTom 64 (NL4100)；OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 觀察階段 6.0Fujifilm Corporation K253836FCT iStream 階段 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770卡迪克套件GE Medical Systems SCS K253560強化版PCCT邊界Ge Medical Systems, LLC

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。