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FDA 510(k)

颅骨对位系统，带颅骨对位软件和LITT；Cirq颅骨活检对位软件；Cirq颅骨sEEG对位软件；VarioGuide颅骨对位软件；Cirq颅骨LITT对位软件

K号: K243698 · 2025-01-28

申请人Brainlab AG
决定日期2025-01-28
产品代码HAW
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-01-28 under 510(k) number K243698. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT?

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT is a medical device that received FDA 510(k) clearance on 2025-01-28. The listed applicant is Brainlab AG. The 510(k) number is K243698.

When did Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT receive FDA 510(k) clearance?

Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT received FDA 510(k) clearance on 2025-01-28, under 510(k) number K243698.

Who is the listed applicant for Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT?

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 Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT?

The FDA product code for Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT is HAW.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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)

查看所有 50 个设备 →

相关器械（代码：HAW）

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。

K253856Geniant 颅骨（导航神经外科定位机器人）Koh Young Technology, Inc.K261932莱克塞尔® Vantage 立体定向系统Elekta Solutions ABK253663Zeta 导航系统Zeta Surgical, Inc.K253379Stealth AXiS颅部临床应用Medtronic Navigation, Inc.K231897NeuroAlign 软件Medivis, Inc.K251317SOLOPASS 2.0系统Intravent Medical Partners

官方来源

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