AXIR-CX
K号: K213520 · 2022-08-19
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器械摘要
AXIR-CX is the device name listed in this FDA 510(k) record. The listed applicant is Radisen Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K213520. 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 AXIR-CX?
AXIR-CX is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Radisen Co., Ltd.. The 510(k) number is K213520.
When did AXIR-CX receive FDA 510(k) clearance?
AXIR-CX received FDA 510(k) clearance on 2022-08-19, under 510(k) number K213520.
Who is the listed applicant for AXIR-CX?
The FDA 510(k) record lists Radisen Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AXIR-CX?
The FDA product code for AXIR-CX is LLZ.
列明Radisen Co., Ltd.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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