FDA 510(k)

SkyPlate 检測器用於飛利浦射線/輔助攝影系統

K 號：K171461 · 2017-07-07

決定日期2017-07-07

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Dmc GmbH. It received FDA 510(k) clearance on 2017-07-07 under 510(k) number K171461. 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 SkyPlate Detector for Philips Radiography/Fluoroscopy Systems?

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is a medical device that received FDA 510(k) clearance on 2017-07-07. The listed applicant is Philips Medical Systems Dmc GmbH. The 510(k) number is K171461.

When did SkyPlate Detector for Philips Radiography/Fluoroscopy Systems receive FDA 510(k) clearance?

SkyPlate Detector for Philips Radiography/Fluoroscopy Systems received FDA 510(k) clearance on 2017-07-07, under 510(k) number K171461.

Who is the listed applicant for SkyPlate Detector for Philips Radiography/Fluoroscopy Systems?

The FDA 510(k) record lists Philips Medical Systems Dmc GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkyPlate Detector for Philips Radiography/Fluoroscopy Systems?

The FDA product code for SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is MQB.

其他以 Philips Medical Systems Dmc GmbH 為申請人之記錄

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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。

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