3D-Anywhere
K号: K253899 · 2026-07-09
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器械摘要
3D-Anywhere is the device name listed in this FDA 510(k) record. The listed applicant is Provect.AI. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K253899. 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 3D-Anywhere?
3D-Anywhere is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Provect.AI. The 510(k) number is K253899.
When did 3D-Anywhere receive FDA 510(k) clearance?
3D-Anywhere received FDA 510(k) clearance on 2026-07-09, under 510(k) number K253899.
Who is the listed applicant for 3D-Anywhere?
The FDA 510(k) record lists Provect.AI as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for 3D-Anywhere?
The FDA product code for 3D-Anywhere 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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