FDA 510(k)

DICOM 查看器

K号: K153653 · 2016-04-13

决定日期2016-04-13

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

DICOM Viewer is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K153653. 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 DICOM Viewer?

DICOM Viewer is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is Brainlab AG. The 510(k) number is K153653.

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

DICOM Viewer received FDA 510(k) clearance on 2016-04-13, under 510(k) number K153653.

Who is the listed applicant for DICOM Viewer?

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

What is the FDA product code for DICOM Viewer?

The FDA product code for DICOM Viewer is LLZ.

列明Brainlab AG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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