FDA 510(k)

ECHELON 橢圓 V6.0A 體掃描系統

K 號：K172110 · 2018-01-11

申請人Hitachi Healthcare Americas Corporation

決定日期2018-01-11

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

ECHELON OVAL V6.0A MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas Corporation. It received FDA 510(k) clearance on 2018-01-11 under 510(k) number K172110. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ECHELON OVAL V6.0A MRI System?

ECHELON OVAL V6.0A MRI System is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Hitachi Healthcare Americas Corporation. The 510(k) number is K172110.

When did ECHELON OVAL V6.0A MRI System receive FDA 510(k) clearance?

ECHELON OVAL V6.0A MRI System received FDA 510(k) clearance on 2018-01-11, under 510(k) number K172110.

Who is the listed applicant for ECHELON OVAL V6.0A MRI System?

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

What is the FDA product code for ECHELON OVAL V6.0A MRI System?

The FDA product code for ECHELON OVAL V6.0A MRI System is LNH.

其他以 Hitachi Healthcare Americas Corporation 為申請人之記錄

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相關器械（代碼：LNH）

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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