FDA 510(k)

Aperio GT 450 DX

K 號：K232202 · 2024-04-16

決定日期2024-04-16

產品代碼PSY

諮詢委員會PA

決定相當於

器材摘要

Aperio GT 450 DX 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 2024-04-16 under 510(k) number K232202. 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 GT 450 DX?

Aperio GT 450 DX is a medical device that received FDA 510(k) clearance on 2024-04-16. The listed applicant is Leica Biosystems Imaging, Inc.. The 510(k) number is K232202.

When did Aperio GT 450 DX receive FDA 510(k) clearance?

Aperio GT 450 DX received FDA 510(k) clearance on 2024-04-16, under 510(k) number K232202.

Who is the listed applicant for Aperio GT 450 DX?

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 GT 450 DX?

The FDA product code for Aperio GT 450 DX 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 K190332Aperio AT2 DX 系統

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。

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官方來源

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