CustoMED 查看器
K号: K260116 · 2026-06-03
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器械摘要
CustoMED Viewer is the device name listed in this FDA 510(k) record. The listed applicant is CustoMED , Ltd.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260116. 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 CustoMED Viewer?
CustoMED Viewer is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is CustoMED , Ltd.. The 510(k) number is K260116.
When did CustoMED Viewer receive FDA 510(k) clearance?
CustoMED Viewer received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260116.
Who is the listed applicant for CustoMED Viewer?
The FDA 510(k) record lists CustoMED , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CustoMED Viewer?
The FDA product code for CustoMED Viewer is LLZ.
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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
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