FDA 510(k)

Aperio AT2 DX 系統

K 號：K190332 · 2019-05-20

決定日期2019-05-20

產品代碼PSY

諮詢委員會PA

決定相當於

器材摘要

Aperio AT2 DX System is the device name listed in this FDA 510(k) record. The listed applicant is Leica Biosystems Imaging, Inc.. It received FDA 510(k) clearance on 2019-05-20 under 510(k) number K190332. 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 Aperio AT2 DX System?

Aperio AT2 DX System is a medical device that received FDA 510(k) clearance on 2019-05-20. The listed applicant is Leica Biosystems Imaging, Inc.. The 510(k) number is K190332.

When did Aperio AT2 DX System receive FDA 510(k) clearance?

Aperio AT2 DX System received FDA 510(k) clearance on 2019-05-20, under 510(k) number K190332.

Who is the listed applicant for Aperio AT2 DX System?

FDA 510(k) 記錄將萊卡生物系統影像股份有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aperio AT2 DX System?

The FDA product code for Aperio AT2 DX System is PSY.

其他以 Leica Biosystems Imaging, 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。

K253561Aperio iQC DX 軟體 K253554Aperio GT 450 DX；Aperio GT 180 DX K232202Aperio GT 450 DX

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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