Roche数字病理学Dx
K号: K242783 · 2024-12-17
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决定日期2024-12-17
产品代码PSY
咨询委员会PA
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决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明Ventana Medical Systems, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：PSY）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K253554Aperio GT 450 DX；Aperio GT 180 DXLeica Biosystems Imaging, Inc.K260964NanoZoomer S540MD 显微玻片扫描系统Hamamatsu Photonics K.K.K251952维拉斯ightVirasoft CorporationK253606NanoZoomer S20MD 显微玻片扫描系统；NanoZoomer S360MD 显微玻片扫描系统Hamamatsu Photonics K.K.K243871Philips IntelliSite病理解决方案5.1Philips Medical Systems Nederland B.V.K241717E1000 Dx Digital Pathology SolutionShandon Diagnostics Limited
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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