FDA 510(k)

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

K 號：K231709 · 2023-07-12

決定日期2023-07-12

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2023-07-12 under 510(k) number K231709. 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 AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is a medical device that received FDA 510(k) clearance on 2023-07-12. The listed applicant is Radmedix, LLC. The 510(k) number is K231709.

When did AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 receive FDA 510(k) clearance?

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 received FDA 510(k) clearance on 2023-07-12, under 510(k) number K231709.

Who is the listed applicant for AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?

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

What is the FDA product code for AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4?

The FDA product code for AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 is MQB.

其他以 Radmedix, LLC 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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