FDX控制台（DR-ID300CL）软件
K号: K170451 · 2017-03-16
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器械摘要
FDX Console (DR-ID300CL) Software 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 2017-03-16 under 510(k) number K170451. 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 FDX Console (DR-ID300CL) Software?
FDX Console (DR-ID300CL) Software is a medical device that received FDA 510(k) clearance on 2017-03-16. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K170451.
When did FDX Console (DR-ID300CL) Software receive FDA 510(k) clearance?
FDX Console (DR-ID300CL) Software received FDA 510(k) clearance on 2017-03-16, under 510(k) number K170451.
Who is the listed applicant for FDX Console (DR-ID300CL) Software?
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 FDX Console (DR-ID300CL) Software?
The FDA product code for FDX Console (DR-ID300CL) Software is LLZ.
相关临床试验
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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。
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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官方来源
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