FDA 510(k)

3D-SHAPER

K 號：K220822 · 2022-12-09

決定日期2022-12-09

產品代碼KGI

諮詢委員會RA

決定相當於

器材摘要

3D-SHAPER is the device name listed in this FDA 510(k) record. The listed applicant is 3D-Shaper Medical S.L. It received FDA 510(k) clearance on 2022-12-09 under 510(k) number K220822. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3D-SHAPER?

3D-SHAPER is a medical device that received FDA 510(k) clearance on 2022-12-09. The listed applicant is 3D-Shaper Medical S.L. The 510(k) number is K220822.

When did 3D-SHAPER receive FDA 510(k) clearance?

3D-SHAPER received FDA 510(k) clearance on 2022-12-09, under 510(k) number K220822.

Who is the listed applicant for 3D-SHAPER?

The FDA 510(k) record lists 3D-Shaper Medical S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D-SHAPER?

The FDA product code for 3D-SHAPER is KGI.

其他以 3D-Shaper Medical S.L 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。

K2510223D-SHAPER

相關器械（代碼：KGI）

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。

K254072骨視科技Curvebeam AI / Curvebeam, LLC K252718月球阿斯特拉GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K2510223D-SHAPER3D-Shaper Medical S.L K242295BunkerHill BMDBunkerHill Health K243218TBS iNsight (V4)Medimaps Group SA K220402VirtuOstO.N. Diagnostics

官方來源

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