Neuro Insight V1.0
K号: K243681 · 2025-07-23
广告
器械摘要
Neuro Insight V1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Olea Medical S.A.S.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) number K243681. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Neuro Insight V1.0?
Neuro Insight V1.0 is a medical device that received FDA 510(k) clearance on 2025-07-23. The listed applicant is Olea Medical S.A.S.. The 510(k) number is K243681.
When did Neuro Insight V1.0 receive FDA 510(k) clearance?
Neuro Insight V1.0 received FDA 510(k) clearance on 2025-07-23, under 510(k) number K243681.
Who is the listed applicant for Neuro Insight V1.0?
The FDA 510(k) record lists Olea Medical S.A.S. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Neuro Insight V1.0?
The FDA product code for Neuro Insight V1.0 is LLZ.
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Olea Medical S.A.S.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：LLZ）
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。
K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio分析Replasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDS
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。Taiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC
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