蓝色幻影PT
K号: K191821 · 2020-01-23
广告
器械摘要
Blue Phantom PT is the device name listed in this FDA 510(k) record. The listed applicant is Iba Dosimetry GmbH. It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K191821. 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 Blue Phantom PT?
Blue Phantom PT is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Iba Dosimetry GmbH. The 510(k) number is K191821.
When did Blue Phantom PT receive FDA 510(k) clearance?
Blue Phantom PT received FDA 510(k) clearance on 2020-01-23, under 510(k) number K191821.
Who is the listed applicant for Blue Phantom PT?
The FDA 510(k) record lists Iba Dosimetry GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Blue Phantom PT?
The FDA product code for Blue Phantom PT 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Iba Dosimetry GmbH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。
广告