FDA 510(k)

ProRad 2FC 及 ProRad 3NC 靜態射線攝影系統

K 號：K183541 · 2019-01-24

申請人Prognosys Medical Systems Private Limited

決定日期2019-01-24

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems 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 2019-01-24 under 510(k) number K183541. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProRad 2FC and ProRad 3NC Stationary Radiographic Systems?

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Prognosys Medical Systems Private Limited. The 510(k) number is K183541.

When did ProRad 2FC and ProRad 3NC Stationary Radiographic Systems receive FDA 510(k) clearance?

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems received FDA 510(k) clearance on 2019-01-24, under 510(k) number K183541.

Who is the listed applicant for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems?

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 2FC and ProRad 3NC Stationary Radiographic Systems?

The FDA product code for ProRad 2FC and ProRad 3NC Stationary Radiographic Systems is KPR.

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。

K243473PRORAD ATLAS 超輕便型；PRORAD ATLAS 超輕便型+K240771PRORAD X光平面顯示器搭配DROC

相關器械（代碼：KPR）

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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