FDA 510(k)

選擇性螢幕顯示用於HeartSee心臟P.E.T.處理軟體 - HeartSee版本4

K 號：K231731 · 2023-08-21

決定日期2023-08-21

產品代碼KPS

諮詢委員會RA

決定相當於

器材摘要

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is the device name listed in this FDA 510(k) record. The listed applicant is Mcgovern Medical School. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K231731. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is Mcgovern Medical School. The 510(k) number is K231731.

When did Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 receive FDA 510(k) clearance?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 received FDA 510(k) clearance on 2023-08-21, under 510(k) number K231731.

Who is the listed applicant for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

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

What is the FDA product code for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

The FDA product code for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is KPS.

其他以 Mcgovern Medical School 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。

K202679選擇性螢幕顯示 HeartSee 心臟 P.E.T. 處理軟體 - HeartSee 版本 3

相關器械（代碼：KPS）

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。

官方來源

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