FDA 510(k)

羅氏數位病理診斷

K 號：K242783 · 2024-12-17

決定日期2024-12-17

產品代碼PSY

諮詢委員會PA

決定相當於

器材摘要

Roche Digital Pathology Dx is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K242783. The device is classified under product code PSY. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Roche Digital Pathology Dx?

Roche Digital Pathology Dx is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Ventana Medical Systems, Inc.. The 510(k) number is K242783.

When did Roche Digital Pathology Dx receive FDA 510(k) clearance?

Roche Digital Pathology Dx received FDA 510(k) clearance on 2024-12-17, under 510(k) number K242783.

Who is the listed applicant for Roche Digital Pathology Dx?

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

What is the FDA product code for Roche Digital Pathology Dx?

The FDA product code for Roche Digital Pathology Dx is PSY.

其他以 Ventana Medical Systems, 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。

K232879羅氏數位病理診斷 Dx (VENTANA DP 200)K212176CINtec 經驗病理 K172471維特納CD30 (Ber-H2) RxDx測試

相關器械（代碼：PSY）

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。

K253554Aperio GT 450 DX；Aperio GT 180 DXLeica Biosystems Imaging, Inc.K260964NanoZoomer S540MD 檔片掃描系統Hamamatsu Photonics K.K.K251952病毒視野Virasoft Corporation K253606NanoZoomer S20MD 薄片掃描系統；NanoZoomer S360MD 薄片掃描系統Hamamatsu Photonics K.K.K243871飛利浦 IntelliSite 病理解決方案 5.1Philips Medical Systems Nederland B.V.K241717E1000 Dx 電子病理學解決方案Shandon Diagnostics Limited

官方來源

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