SCENARIA View Phase 5.0
K号: K250370 · 2025-05-20
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器械摘要
SCENARIA View Phase 5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K250370. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SCENARIA View Phase 5.0?
SCENARIA View Phase 5.0 is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is Fujifilm Corporation. The 510(k) number is K250370.
When did SCENARIA View Phase 5.0 receive FDA 510(k) clearance?
SCENARIA View Phase 5.0 received FDA 510(k) clearance on 2025-05-20, under 510(k) number K250370.
Who is the listed applicant for SCENARIA View Phase 5.0?
FDA 510(k)记录中列出富士胶片公司为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for SCENARIA View Phase 5.0?
The FDA product code for SCENARIA View Phase 5.0 is JAK.
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Fujifilm Corporation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:JAK)
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。
K261125BodyTom 64(NL4100);OmniTom Elite(NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA 视觉阶段 6.0Fujifilm CorporationK253836FCT iStream 阶段 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ 套件GE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC
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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