Spectral CT
K号: K244008 · 2025-05-16
广告
器械摘要
Spectral CT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Technologies , Ltd.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K244008. 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 Spectral CT?
Spectral CT is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Philips Medical Systems Technologies , Ltd.. The 510(k) number is K244008.
When did Spectral CT receive FDA 510(k) clearance?
Spectral CT received FDA 510(k) clearance on 2025-05-16, under 510(k) number K244008.
Who is the listed applicant for Spectral CT?
The FDA 510(k) record lists Philips Medical Systems Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Spectral CT?
The FDA product code for Spectral CT 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Philips Medical Systems Technologies , Ltd.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。
广告