E1000 Dx Digital Pathology Solution
K号: K241717 · 2025-02-28
广告
决定日期2025-02-28
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
E1000 Dx Digital Pathology Solution is the device name listed in this FDA 510(k) record. The listed applicant is Shandon Diagnostics Limited. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K241717. 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 E1000 Dx Digital Pathology Solution?
E1000 Dx Digital Pathology Solution is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Shandon Diagnostics Limited. The 510(k) number is K241717.
When did E1000 Dx Digital Pathology Solution receive FDA 510(k) clearance?
E1000 Dx Digital Pathology Solution received FDA 510(k) clearance on 2025-02-28, under 510(k) number K241717.
Who is the listed applicant for E1000 Dx Digital Pathology Solution?
The FDA 510(k) record lists Shandon Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E1000 Dx Digital Pathology Solution?
The FDA product code for E1000 Dx Digital Pathology Solution 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。
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.K242783Roche数字病理学DxVentana Medical Systems, Inc.
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