Aperio AT2 DX系统
K号: K190332 · 2019-05-20
广告
决定日期2019-05-20
产品代码PSY
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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)记录中列出了Leica Biosystems Imaging, Inc.为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for Aperio AT2 DX System?
The FDA product code for Aperio AT2 DX System 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Leica Biosystems Imaging, 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。
广告