FDA 510(k)

Nanox.ARC

K 號：K242395 · 2024-12-04

決定日期2024-12-04

產品代碼IZF

諮詢委員會RA

決定相當於

器材摘要

Nanox.ARC is the device name listed in this FDA 510(k) record. The listed applicant is Nano-X Imaging , Ltd.. It received FDA 510(k) clearance on 2024-12-04 under 510(k) number K242395. The device is classified under product code IZF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Nanox.ARC?

Nanox.ARC is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Nano-X Imaging , Ltd.. The 510(k) number is K242395.

When did Nanox.ARC receive FDA 510(k) clearance?

Nanox.ARC received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242395.

Who is the listed applicant for Nanox.ARC?

The FDA 510(k) record lists Nano-X Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nanox.ARC?

The FDA product code for Nanox.ARC is IZF.

其他以 Nano-X Imaging , Ltd. 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。

K252649TAP2D K250850Nanox.ARC X K222934Nanox.ARC K203782Nanox Cart 閃光機系統

相關器械（代碼：IZF）

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。

K252649TAP2DNano-X Imaging , Ltd.K252133Adaptix Ortho350Adaptix Limited K250850Nanox.ARC XNano-X Imaging , Ltd.K222934Nanox.ARCNano-X Imaging , Ltd.K221949Ortho Device，ADAPTIX 3D 骨科影像系統Pausch Medical GmbH K213081CLISIS SYSTEMS, Discovery RF180General Medical Merate S.P.A

官方來源

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