FDA 510(k)

SKR 3000

K 號：K223267 · 2022-11-17

決定日期2022-11-17

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

SKR 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Konica Minolta, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K223267. 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 SKR 3000?

SKR 3000 is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Konica Minolta, Inc.. The 510(k) number is K223267.

When did SKR 3000 receive FDA 510(k) clearance?

SKR 3000 received FDA 510(k) clearance on 2022-11-17, under 510(k) number K223267.

Who is the listed applicant for SKR 3000?

The FDA 510(k) record lists Konica Minolta, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKR 3000?

The FDA product code for SKR 3000 is MQB.

其他以 Konica Minolta, Inc. 為申請人之記錄

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K250665SKR 3000 K241319SKR 3000 K240281骨抑制軟體 K230906佳能美能達 DI-X1 K220993超音波系統 SONIMAGE MX1 K213908SKR 3000

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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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