FDA 510(k)

SurgiCase Viewer

K号: K213684 · 2022-06-15

决定日期2022-06-15

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

SurgiCase Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2022-06-15 under 510(k) number K213684. 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 SurgiCase Viewer?

SurgiCase Viewer is a medical device that received FDA 510(k) clearance on 2022-06-15. The listed applicant is Materialise NV. The 510(k) number is K213684.

When did SurgiCase Viewer receive FDA 510(k) clearance?

SurgiCase Viewer received FDA 510(k) clearance on 2022-06-15, under 510(k) number K213684.

Who is the listed applicant for SurgiCase Viewer?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SurgiCase Viewer?

The FDA product code for SurgiCase Viewer is LLZ.

列明Materialise NV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。

K260802Materialise肩关节系统™，Materialise肩关节引导和模型，SurgiCase肩关节规划器 K251964Mimics 胸部规划器 K253308Materialise 针对颅面外科手术的个性化引导和模型 CMF 钛制引导；CMF 塑料模型 K253793Materialise全膝关节置换术引导系统 K251554Materialise全膝关节置换术引导系统 K243637Materialise 针对颅面外科手术的个性化引导和模型

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官方来源

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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。