免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

维特拉CT双能量图像查看器

K号: K161157 · 2016-11-03

决定日期2016-11-03
产品代码JAK
咨询委员会RA
决定实质等同

器械摘要

Vitrea CT Dual Energy Image View is the device name listed in this FDA 510(k) record. The listed applicant is Vital Images, Inc.. It received FDA 510(k) clearance on 2016-11-03 under 510(k) number K161157. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vitrea CT Dual Energy Image View?

Vitrea CT Dual Energy Image View is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Vital Images, Inc.. The 510(k) number is K161157.

When did Vitrea CT Dual Energy Image View receive FDA 510(k) clearance?

Vitrea CT Dual Energy Image View received FDA 510(k) clearance on 2016-11-03, under 510(k) number K161157.

Who is the listed applicant for Vitrea CT Dual Energy Image View?

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

What is the FDA product code for Vitrea CT Dual Energy Image View?

The FDA product code for Vitrea CT Dual Energy Image View is JAK.

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。

列明Vital Images, 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。

查看所有 8 个设备 →

相关器械(代码:JAK)

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。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

↑