FCT iSTREAM 1期
K号: K233583 · 2024-04-26
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器械摘要
FCT iSTREAM Phase 1 is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-04-26 under 510(k) number K233583. 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 FCT iSTREAM Phase 1?
FCT iSTREAM Phase 1 is a medical device that received FDA 510(k) clearance on 2024-04-26. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233583.
When did FCT iSTREAM Phase 1 receive FDA 510(k) clearance?
FCT iSTREAM Phase 1 received FDA 510(k) clearance on 2024-04-26, under 510(k) number K233583.
Who is the listed applicant for FCT iSTREAM Phase 1?
The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FCT iSTREAM Phase 1?
The FDA product code for FCT iSTREAM Phase 1 is JAK.
相关临床试验
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列明FUJIFILM Healthcare Americas 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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