ECG CT 门控装置
K号: K160350 · 2016-06-16
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器械摘要
ECG CT Gating Device is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K160350. 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 ECG CT Gating Device?
ECG CT Gating Device is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Neocoil, LLC. The 510(k) number is K160350.
When did ECG CT Gating Device receive FDA 510(k) clearance?
ECG CT Gating Device received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160350.
Who is the listed applicant for ECG CT Gating Device?
The FDA 510(k) record lists Neocoil, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ECG CT Gating Device?
The FDA product code for ECG CT Gating Device 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Neocoil, LLC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。
K2609470.55T 12Ch乳腺线圈K22240716ch 母乳线圈 / 16ch 母乳线圈，1.5T 16ch 母乳线圈，3.0T 16ch 母乳线圈，1.5T 16ch 母乳线圈，3T 16ch 母乳线圈K21368732Ch AIR 开放线圈套件：1.5T AIR 开放头颈后部 9ch / 3.0T AIR 开放头颈后部 9ch，1.5T AIR 开放颈部胸部前部 7ch / 3.0T AIR 开放颈部胸部前部 7ch，1.5T AIR 开放头前部 16ch / 3.0T AIR 开放头前部 16chK2011011.5T 16ch 肩部线圈，3.0T 16ch 肩部线圈K1829581.5T 16ch 乳腺线圈K173409无线音频系统
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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