FDA 510(k)

血管导航 PAD 2.0；血管导航软件 Vascular PAD

K号: K243432 · 2025-07-22

决定日期2025-07-22

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K243432. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Brainlab AG. The 510(k) number is K243432.

When did Vascular Navigation PAD 2.0; Navigation Software Vascular PAD receive FDA 510(k) clearance?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD received FDA 510(k) clearance on 2025-07-22, under 510(k) number K243432.

Who is the listed applicant for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

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 Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

The FDA product code for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is OWB.

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 Instruments K243142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 RT K243633Brainlab 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)K242569混合现实脊柱导航

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