FDA 510(k)

xR IVD

K 號：K241868 · 2025-09-19

決定日期2025-09-19

產品代碼PZM

諮詢委員會PA

決定Substantially Equivalent

器材摘要

xR IVD is the device name listed in this FDA 510(k) record. The listed applicant is Tempus AI, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K241868. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the xR IVD?

xR IVD is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Tempus AI, Inc.. The 510(k) number is K241868.

When did xR IVD receive FDA 510(k) clearance?

xR IVD received FDA 510(k) clearance on 2025-09-19, under 510(k) number K241868.

Who is the listed applicant for xR IVD?

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

What is the FDA product code for xR IVD?

The FDA product code for xR IVD is PZM.

其他以 Tempus AI, Inc. 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。

K254297Tempus ECG-MR K253699Tempus ECG-PH K250119Tempus ECG-Low EF K233549Tempus ECG-AF

相關器械（代碼：PZM）

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。

K260235CellDx-TissueDatar Cancer Genetics Private Limited K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc.K210017ACTOnco，ACTOnco IVDAct Genomics K202304NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)Nyu Langone Medical Center K192063PGDx elio tissue completePersonal Genome Diagnostics K190661Omics CoreNanthealth, Inc.

官方來源

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