Acteon 成像套件
K号: K192165 · 2020-02-11
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器械摘要
Acteon Imaging Suite is the device name listed in this FDA 510(k) record. The listed applicant is De Gotzen S.R.L.. It received FDA 510(k) clearance on 2020-02-11 under 510(k) number K192165. 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 Acteon Imaging Suite?
Acteon Imaging Suite is a medical device that received FDA 510(k) clearance on 2020-02-11. The listed applicant is De Gotzen S.R.L.. The 510(k) number is K192165.
When did Acteon Imaging Suite receive FDA 510(k) clearance?
Acteon Imaging Suite received FDA 510(k) clearance on 2020-02-11, under 510(k) number K192165.
Who is the listed applicant for Acteon Imaging Suite?
The FDA 510(k) record lists De Gotzen S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Acteon Imaging Suite?
The FDA product code for Acteon Imaging Suite is LLZ.
相关临床试验
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列明De Gotzen S.R.L.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。
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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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