AmCAD-UT Detection 2.2
K号: K180006 · 2018-08-31
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器械摘要
AmCAD-UT Detection 2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Amcad Biomed Corporation. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K180006. 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 AmCAD-UT Detection 2.2?
AmCAD-UT Detection 2.2 is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Amcad Biomed Corporation. The 510(k) number is K180006.
When did AmCAD-UT Detection 2.2 receive FDA 510(k) clearance?
AmCAD-UT Detection 2.2 received FDA 510(k) clearance on 2018-08-31, under 510(k) number K180006.
Who is the listed applicant for AmCAD-UT Detection 2.2?
The FDA 510(k) record lists Amcad Biomed Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AmCAD-UT Detection 2.2?
The FDA product code for AmCAD-UT Detection 2.2 is LLZ.
相关临床试验
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列明Amcad Biomed Corporation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。
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