FDA 510(k)

Dynamic Visualization II 图像处理选项，用于FDX控制台（DR-ID300CL of the DR-ID600）

K号: K163624 · 2017-06-30

决定日期2017-06-30

产品代码MQB

咨询委员会RA

决定实质等同

器械摘要

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K163624. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K163624.

When did Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) receive FDA 510(k) clearance?

Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) received FDA 510(k) clearance on 2017-06-30, under 510(k) number K163624.

Who is the listed applicant for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)?

The FDA product code for Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) is MQB.

列明Fujifilm Medical Systems U.S.A, Inc.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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