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FDA 510(k)

3D Bolus軟體應用程序，3D Brachy軟體應用程序，患者匹配3D打印放射治療配件

K 號：K213438 · 2022-01-19

申請人Adaptiiv
決定日期2022-01-19
產品代碼MUJ
諮詢委員會RA
決定相當於

器材摘要

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Adaptiiv. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K213438. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory?

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Adaptiiv. The 510(k) number is K213438.

When did 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory receive FDA 510(k) clearance?

3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory received FDA 510(k) clearance on 2022-01-19, under 510(k) number K213438.

Who is the listed applicant for 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory?

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

What is the FDA product code for 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory?

The FDA product code for 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory is MUJ.

相關臨床試驗

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：MUJ）

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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