FDA 510(k)

Aquarius 8600

K 號：K170202 · 2017-02-22

決定日期2017-02-22

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Aquarius 8600 is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Dynamics Company , Ltd.. It received FDA 510(k) clearance on 2017-02-22 under 510(k) number K170202. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aquarius 8600?

Aquarius 8600 is a medical device that received FDA 510(k) clearance on 2017-02-22. The listed applicant is Imaging Dynamics Company , Ltd.. The 510(k) number is K170202.

When did Aquarius 8600 receive FDA 510(k) clearance?

Aquarius 8600 received FDA 510(k) clearance on 2017-02-22, under 510(k) number K170202.

Who is the listed applicant for Aquarius 8600?

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

What is the FDA product code for Aquarius 8600?

The FDA product code for Aquarius 8600 is MQB.

其他以 Imaging Dynamics Company , 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。

K173273Aquarius 8600 1417WCI; Aquarius 8600 1717WCI K171169Aquarius 8600 1417TG 及 Aquarius 8600 1717TG K171175Aquarius 8600 1417WC

相關器械（代碼：MQB）

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。

K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530偵測器（Lux HD 2530）Iray Imaging Technology (Haining) Limited K250211玉山X光平面面板檢測器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

官方來源

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