FDA 510(k)

PRORAD X光平面顯示器搭配DROC

K 號：K240771 · 2024-11-12

申請人Prognosys Medical Systems Private Limited

決定日期2024-11-12

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

PRORAD X-Ray Flat Panel Detector with DROC is the device name listed in this FDA 510(k) record. The listed applicant is Prognosys Medical Systems Private Limited. It received FDA 510(k) clearance on 2024-11-12 under 510(k) number K240771. 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 PRORAD X-Ray Flat Panel Detector with DROC?

PRORAD X-Ray Flat Panel Detector with DROC is a medical device that received FDA 510(k) clearance on 2024-11-12. The listed applicant is Prognosys Medical Systems Private Limited. The 510(k) number is K240771.

When did PRORAD X-Ray Flat Panel Detector with DROC receive FDA 510(k) clearance?

PRORAD X-Ray Flat Panel Detector with DROC received FDA 510(k) clearance on 2024-11-12, under 510(k) number K240771.

Who is the listed applicant for PRORAD X-Ray Flat Panel Detector with DROC?

The FDA 510(k) record lists Prognosys Medical Systems Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRORAD X-Ray Flat Panel Detector with DROC?

The FDA product code for PRORAD X-Ray Flat Panel Detector with DROC is MQB.

其他以 Prognosys Medical Systems Private Limited 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。

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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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官方來源

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