FDA 510(k)

Welch Allyn RetinaVue网络 REF 901108 PACS医学影像系统

K号: K181016 · 2018-07-16

决定日期2018-07-16

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2018-07-16 under 510(k) number K181016. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is a medical device that received FDA 510(k) clearance on 2018-07-16. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K181016.

When did Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System receive FDA 510(k) clearance?

Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System received FDA 510(k) clearance on 2018-07-16, under 510(k) number K181016.

Who is the listed applicant for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

The FDA 510(k) record lists Welch Allyn, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System?

The FDA product code for Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System is NFJ.

列明Welch Allyn, 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。

K243598Welch Allyn Connex® 360（多款）K241411Welch Allyn Connex® 即时监测仪；901058 生命体征监测仪核心（CSM）K223381iExaminer系统 Panoptic Plus K212473韦尔奇·艾略恩康奈克斯中央站 K191013韦尔奇·艾琳诊断心脏病学套件 2.X.X 带肺功能检测选项 K171621韦尔奇·艾利恩 Connex 生命体征监测仪，韦尔奇·艾利恩 Connex 集成式壁挂系统，901060 生命体征监测仪

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