FDA 510(k)

SonoVision超声成像系统

K号: K192388 · 2020-03-12

申请人Tissue Differentiation Intelligence, LLC

决定日期2020-03-12

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

SonoVision Ultrasound Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Differentiation Intelligence, LLC. It received FDA 510(k) clearance on 2020-03-12 under 510(k) number K192388. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SonoVision Ultrasound Imaging System?

SonoVision Ultrasound Imaging System is a medical device that received FDA 510(k) clearance on 2020-03-12. The listed applicant is Tissue Differentiation Intelligence, LLC. The 510(k) number is K192388.

When did SonoVision Ultrasound Imaging System receive FDA 510(k) clearance?

SonoVision Ultrasound Imaging System received FDA 510(k) clearance on 2020-03-12, under 510(k) number K192388.

Who is the listed applicant for SonoVision Ultrasound Imaging System?

The FDA 510(k) record lists Tissue Differentiation Intelligence, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SonoVision Ultrasound Imaging System?

The FDA product code for SonoVision Ultrasound Imaging System is IYN.

相关器械（代码：IYN）

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。

器械摘要

常见问题

相关临床试验

相关器械（代码：IYN）

官方来源