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FDA 510(k)

QDOSE® 多功能體素劑量學（分子放射治療個體化劑量學）

K 號：K230221 · 2023-08-28

申請人Versant Medical Physics and Radiation Safety
決定日期2023-08-28
產品代碼IYX
諮詢委員會RA
決定相當於

器材摘要

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) is the device name listed in this FDA 510(k) record. The listed applicant is Versant Medical Physics and Radiation Safety. It received FDA 510(k) clearance on 2023-08-28 under 510(k) number K230221. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)?

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) is a medical device that received FDA 510(k) clearance on 2023-08-28. The listed applicant is Versant Medical Physics and Radiation Safety. The 510(k) number is K230221.

When did QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) receive FDA 510(k) clearance?

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) received FDA 510(k) clearance on 2023-08-28, under 510(k) number K230221.

Who is the listed applicant for QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)?

The FDA 510(k) record lists Versant Medical Physics and Radiation Safety as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)?

The FDA product code for QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) is IYX.

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：IYX）

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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