FDA 510(k)

syngo®.via protoNeo（版本VA10A）

K号: K161685 · 2016-07-11

决定日期2016-07-11

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

syngo®.via protoNeo (Version VA10A) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2016-07-11 under 510(k) number K161685. 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 syngo®.via protoNeo (Version VA10A)?

syngo®.via protoNeo (Version VA10A) is a medical device that received FDA 510(k) clearance on 2016-07-11. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K161685.

When did syngo®.via protoNeo (Version VA10A) receive FDA 510(k) clearance?

syngo®.via protoNeo (Version VA10A) received FDA 510(k) clearance on 2016-07-11, under 510(k) number K161685.

Who is the listed applicant for syngo®.via protoNeo (Version VA10A)?

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

What is the FDA product code for syngo®.via protoNeo (Version VA10A)?

The FDA product code for syngo®.via protoNeo (Version VA10A) is LLZ.

列明Siemens Healthcare GmbH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。

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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。