VuePoint 光学相干断层扫描（OCT）系统
K号: K153336 · 2016-01-07
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决定日期2016-01-07
产品代码NKG
咨询委员会OR
请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整：
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产品名称：[产品名称]
公司名称：[公司名称]
根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。
产品注册号：[注册号]
PMA编号：[PMA编号]
临床试验编号（NCT）：[NCT编号]
PubMed ID（PMID）：[PMID编号]
更多信息请访问以下链接：
[URL]
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请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同
器械摘要
VuePoint OCT System is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K153336. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VuePoint OCT System?
VuePoint OCT System is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K153336.
When did VuePoint OCT System receive FDA 510(k) clearance?
VuePoint OCT System received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153336.
Who is the listed applicant for VuePoint OCT System?
The FDA 510(k) record lists Nu Vasive, Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VuePoint OCT System?
The FDA product code for VuePoint OCT System is NKG.
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Nu Vasive, Incorporated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。
K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody SystemK230894NuVasive Modulus ALIF SystemK230989Rod 注册框架K223181NuVasive Reline 系统K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceK221388NuVasive Reline 颈椎系统
相关器械（代码：NKG）
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。
K254260VEGA 颈椎螺钉系统GS Medical Co., Ltd.K253195TAURUS 后枕颈胸脊髓系统ZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® 后颈椎螺钉系统；CarboClear® 混合后颈椎螺钉系统CarboFix Orthopedics , Ltd.K254165Infinity® OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT 系统；CMORE® CT 系统导航工具Icotec AGK253129Infinity® OCT SystemMedtronic Sofamor Danek USA, Inc.
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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