P-Cure质子束治疗系统
K号: K221996 · 2023-03-20
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器械摘要
P-Cure Proton Beam Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is P-Cure, Ltd.. It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K221996. 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 P-Cure Proton Beam Therapy System?
P-Cure Proton Beam Therapy System is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is P-Cure, Ltd.. The 510(k) number is K221996.
When did P-Cure Proton Beam Therapy System receive FDA 510(k) clearance?
P-Cure Proton Beam Therapy System received FDA 510(k) clearance on 2023-03-20, under 510(k) number K221996.
Who is the listed applicant for P-Cure Proton Beam Therapy System?
The FDA 510(k) record lists P-Cure, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for P-Cure Proton Beam Therapy System?
The FDA product code for P-Cure Proton Beam 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。
列明P-Cure, 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：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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