ProNova SC360质子治疗系统
K号: K162246 · 2016-12-08
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器械摘要
ProNova SC360 Proton Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Pronova Solutions, LLC. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K162246. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ProNova SC360 Proton Therapy System?
ProNova SC360 Proton Therapy System is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Pronova Solutions, LLC. The 510(k) number is K162246.
When did ProNova SC360 Proton Therapy System receive FDA 510(k) clearance?
ProNova SC360 Proton Therapy System received FDA 510(k) clearance on 2016-12-08, under 510(k) number K162246.
Who is the listed applicant for ProNova SC360 Proton Therapy System?
The FDA 510(k) record lists Pronova Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ProNova SC360 Proton Therapy System?
The FDA product code for ProNova SC360 Proton Therapy System is LHN.
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。
相关器械（代码：LHN）
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。
K260597VIRTUE 质量认证ProNova SolutionsK260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT 质子束放射治疗设备 (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT 质子束放射治疗设备 (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus 呼吸运动管理系统Empnia, 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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