FDA 510(k)

Axial3D雲端斷層描繪服務

K 號：K221511 · 2022-06-23

決定日期2022-06-23

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Axial3D Cloud Segmentation Service is the device name listed in this FDA 510(k) record. The listed applicant is Axial Medical Printing Limited. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K221511. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Axial3D Cloud Segmentation Service?

Axial3D Cloud Segmentation Service is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Axial Medical Printing Limited. The 510(k) number is K221511.

When did Axial3D Cloud Segmentation Service receive FDA 510(k) clearance?

Axial3D Cloud Segmentation Service received FDA 510(k) clearance on 2022-06-23, under 510(k) number K221511.

Who is the listed applicant for Axial3D Cloud Segmentation Service?

The FDA 510(k) record lists Axial Medical Printing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Axial3D Cloud Segmentation Service?

The FDA product code for Axial3D Cloud Segmentation Service is LLZ.

其他以 Axial Medical Printing 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。

K250369Axial3D洞察 K231607Axial3D雲端斷層描繪服務 K232841Axial3D洞察 K222745Axial3D洞察

相關器械（代碼：LLZ）

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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