FDA 510(k)

AcuityDR 1013 G4、AcuityDR 1417 G4、AcuityDR 1717G4

K番号: K231709 · 2023-07-12

決定日2023-07-12

製品コードMQB

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてRadmedix, LLCを記載するその他の記録

K231995AcuityUDR K210919AcuityDRe K201058Accuvue+K200726AcuityPDR K193360Acuity SDR Standard、Acuity SDR Plus、Acuity FDR Standard

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