FDA 510(k)

謹慎 1717，謹慎 1417，謹慎 1212

K 號：K211108 · 2021-06-04

決定日期2021-06-04

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Prudent 1717, Prudent 1417, Prudent 1212 is the device name listed in this FDA 510(k) record. The listed applicant is Pixxgen Corporation. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K211108. 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 Prudent 1717, Prudent 1417, Prudent 1212?

Prudent 1717, Prudent 1417, Prudent 1212 is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Pixxgen Corporation. The 510(k) number is K211108.

When did Prudent 1717, Prudent 1417, Prudent 1212 receive FDA 510(k) clearance?

Prudent 1717, Prudent 1417, Prudent 1212 received FDA 510(k) clearance on 2021-06-04, under 510(k) number K211108.

Who is the listed applicant for Prudent 1717, Prudent 1417, Prudent 1212?

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

What is the FDA product code for Prudent 1717, Prudent 1417, Prudent 1212?

The FDA product code for Prudent 1717, Prudent 1417, Prudent 1212 is MQB.

其他以 Pixxgen Corporation 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。

K190691Pixx2430數位診斷X光接收器面板 K182533PIXX 1717；PIXX 1417；PIXX 1212；數位診斷X光受訓面板 K180976PIXX 1717；PIXX 1417；PIXX 1212；數位診斷X光受訓面板

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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