ExacTrac 动态 1.1.2
K号: K231052 · 2023-05-11
广告
器械摘要
ExacTrac Dynamic 1.1.2 is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2023-05-11 under 510(k) number K231052. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ExacTrac Dynamic 1.1.2?
ExacTrac Dynamic 1.1.2 is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Brainlab AG. The 510(k) number is K231052.
When did ExacTrac Dynamic 1.1.2 receive FDA 510(k) clearance?
ExacTrac Dynamic 1.1.2 received FDA 510(k) clearance on 2023-05-11, under 510(k) number K231052.
Who is the listed applicant for ExacTrac Dynamic 1.1.2?
The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ExacTrac Dynamic 1.1.2?
The FDA product code for ExacTrac Dynamic 1.1.2 is IYE.
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Brainlab AG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。
K252476查看器（5.4）；元素查看器；混合现实查看器；智能布局；元素查看器智能布局K252562Spine & Trauma Navigation InstrumentsK243432血管导航 PAD 2.0；血管导航软件 Vascular PADK243142颅骨4Pi固定装置K250440RT Elements (4.5); (Elements) 多个脑转移SRS; (Elements) 颅脑SRS; (Elements) 脊柱SRS; (Elements) 颅脑SRS带锥形; (Elements) RT 计划平台; (Elements) 剂量审查; (Elements) 重新治疗审查; Elements 分割 [颅脑，基底神经节，头颈，盆腔，脊柱，胸椎和脊柱，颅外] RT; Elements AI 肿瘤分割 RT; Elements SmartBrush [血管，脊柱] RT; Elements 对象管理 RTK243633Brainlab Elements (7.0)；Brainlab Elements Image Fusion (5.0)；Brainlab Elements Image Fusion Angio (1.0)；Brainlab Elements Contouring (5.0)；Brainlab Elements Fibertracking (3.0)；Brainlab Elements BOLD MRI Mapping (1.0)
相关器械（代码：IYE）
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。
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