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FDA 510(k)

富士胶片超声处理器 SP-900 和富士胶片超声探头 PB2020-M

K号: K171207 · 2018-01-11

申请人Fujifilm Medical Systems U.S.A, Inc.
决定日期2018-01-11
产品代码ODG
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M 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 2018-01-11 under 510(k) number K171207. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is a medical device that received FDA 510(k) clearance on 2018-01-11. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171207.

When did FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M receive FDA 510(k) clearance?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M received FDA 510(k) clearance on 2018-01-11, under 510(k) number K171207.

Who is the listed applicant for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

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 Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

The FDA product code for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is ODG.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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-530PK173132ASPIRE CristalleK171463ASPIRE Bellus IIK152257富士十二指肠镜型号ED-530XTK163624Dynamic 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

查看所有 16 个设备 →

相关器械（代码：ODG）

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。

K261183EVIS EUS 超声胃肠内窥镜（Olympus GF-UE190）Olympus Medical Systems CorporationK260428RIVOS™ EUS 访问装置 (M00553900)Boston Scientific CorporationK251859EVIS EUS 超声胃肠内窥镜（Olympus GF-UE190）Olympus Medical Systems CorporationK251542InstaFANOnepass Medical , Ltd.K231813超声胃镜Sonoscape Medical Corp.K232518EndoSound Vision System; EVSEndosound, Inc.

官方来源

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