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FDA 510(k)

掃描側劑量檢查

K 號:K171261 · 2017-08-18

決定日期2017-08-18
產品代碼JAK
諮詢委員會RA
決定相當於

器材摘要

ScannerSide DoseCheck is the device name listed in this FDA 510(k) record. The listed applicant is Right Dose, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K171261. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ScannerSide DoseCheck?

ScannerSide DoseCheck is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is Right Dose, Inc.. The 510(k) number is K171261.

When did ScannerSide DoseCheck receive FDA 510(k) clearance?

ScannerSide DoseCheck received FDA 510(k) clearance on 2017-08-18, under 510(k) number K171261.

Who is the listed applicant for ScannerSide DoseCheck?

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

What is the FDA product code for ScannerSide DoseCheck?

The FDA product code for ScannerSide DoseCheck is JAK.

相關臨床試驗

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相關器械(代碼:JAK)

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。

官方來源

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