FDA 510(k)

放射線計画アシスタント（RPA）

K番号: K222728 · 2023-05-17

申請者University of Texas, MD Anderson Cancer Center

決定日2023-05-17

製品コードMUJ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

Radiation Planning Assistant (RPA) is the device name listed in this FDA 510(k) record. The listed applicant is University of Texas, MD Anderson Cancer Center. It received FDA 510(k) clearance on 2023-05-17 under 510(k) number K222728. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Radiation Planning Assistant (RPA)?

Radiation Planning Assistant (RPA) is a medical device that received FDA 510(k) clearance on 2023-05-17. The listed applicant is University of Texas, MD Anderson Cancer Center. The 510(k) number is K222728.

When did Radiation Planning Assistant (RPA) receive FDA 510(k) clearance?

Radiation Planning Assistant (RPA) received FDA 510(k) clearance on 2023-05-17, under 510(k) number K222728.

Who is the listed applicant for Radiation Planning Assistant (RPA)?

The FDA 510(k) record lists University of Texas, MD Anderson Cancer Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radiation Planning Assistant (RPA)?

The FDA product code for Radiation Planning Assistant (RPA) is MUJ.

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放射線計画アシスタント（RPA）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：MUJ）

公式ソース