FDA 510(k)

智慧網格

K 號：K163157 · 2017-03-21

決定日期2017-03-21

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

SmartGrid is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health. It received FDA 510(k) clearance on 2017-03-21 under 510(k) number K163157. 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 SmartGrid?

SmartGrid is a medical device that received FDA 510(k) clearance on 2017-03-21. The listed applicant is Carestream Health. The 510(k) number is K163157.

When did SmartGrid receive FDA 510(k) clearance?

SmartGrid received FDA 510(k) clearance on 2017-03-21, under 510(k) number K163157.

Who is the listed applicant for SmartGrid?

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

What is the FDA product code for SmartGrid?

The FDA product code for SmartGrid is MQB.

其他以 Carestream Health 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。

K253185Lux HD 檢測器，DRX-LC 檢測器，DRX-Revolution 移動 X 光系統 K250954DRX-Evolution Plus 電影系統，DRX-Compass 流動電影系統，Lux HD 35 探測器，Lux HD 43 探測器 K213568DRX-Rise 電子攝影機移動式X光系統 K203159Lux 35 检測器

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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