FDA 510(k)

赫爾墨斯醫學影像套件 v5.7

K 號：K171681 · 2017-11-21

決定日期2017-11-21

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

Hermes Medical Imaging Suite v5.7 is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K171681. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hermes Medical Imaging Suite v5.7?

Hermes Medical Imaging Suite v5.7 is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K171681.

When did Hermes Medical Imaging Suite v5.7 receive FDA 510(k) clearance?

Hermes Medical Imaging Suite v5.7 received FDA 510(k) clearance on 2017-11-21, under 510(k) number K171681.

Who is the listed applicant for Hermes Medical Imaging Suite v5.7?

FDA 510(k) 記錄將 Hermes Medical Solutions AB 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Hermes Medical Imaging Suite v5.7?

The FDA product code for Hermes Medical Imaging Suite v5.7 is KPS.

其他以 Hermes Medical Solutions AB 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：KPS）

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。

官方來源

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