FDA 510(k)

富士十二指肠镜型号ED-530XT

K号: K152257 · 2017-07-21

决定日期2017-07-21

产品代码FDT

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决定实质等同

器械摘要

Fujifilm Duodenoscope Model ED-530XT 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 2017-07-21 under 510(k) number K152257. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Fujifilm Duodenoscope Model ED-530XT?

Fujifilm Duodenoscope Model ED-530XT is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K152257.

When did Fujifilm Duodenoscope Model ED-530XT receive FDA 510(k) clearance?

Fujifilm Duodenoscope Model ED-530XT received FDA 510(k) clearance on 2017-07-21, under 510(k) number K152257.

Who is the listed applicant for Fujifilm Duodenoscope Model ED-530XT?

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 Fujifilm Duodenoscope Model ED-530XT?

The FDA product code for Fujifilm Duodenoscope Model ED-530XT is FDT.

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。

K171291FUJIFILM 支气管镜型号 EB-530P K171207富士胶片超声处理器 SP-900 和富士胶片超声探头 PB2020-M K173132ASPIRE Cristalle K171463ASPIRE Bellus II K163624Dynamic Visualization II 图像处理选项，用于FDX控制台（DR-ID300CL of the DR-ID600）K162749富士胶片罩子型号DH-28GR, DH-29CR和DH-30CR

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相关器械（代码：FDT）

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。

K251861富士胶片内窥镜型号ED-S100TP; 富士胶片内窥镜型号ED-S100XP; 富士胶片处理器型号VS-1000Fujifilm Corporation K253646一次性远端盖 MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III 十二指肠镜 OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III十二指肠内窥镜Olympus TJF-Q190V（TJF-Q190V）Olympus Medical Systems Corp.K233942PENTAX 医疗视频十二指肠镜 (ED34-i10T2s)；PENTAX 医疗视频处理器 (EPK-i8020c)；PENTAX 医疗一次性，无菌远端帽带提升器 (OE-A63)；气/水供应阀门 (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

官方来源

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