Philips Incisive CT
K号: K212441 · 2022-04-27
广告
器械摘要
Philips Incisive CT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K212441. 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 Philips Incisive CT?
Philips Incisive CT is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K212441.
When did Philips Incisive CT receive FDA 510(k) clearance?
Philips Incisive CT received FDA 510(k) clearance on 2022-04-27, under 510(k) number K212441.
Who is the listed applicant for Philips Incisive CT?
The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Philips Incisive CT?
The FDA product code for Philips Incisive 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 Healthcare (Suzhou) Co., 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