FDA 510(k)

ACUSON S3000 S2000 S1000诊断超声系统

K号: K172162 · 2017-08-16

决定日期2017-08-16

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare. It received FDA 510(k) clearance on 2017-08-16 under 510(k) number K172162. 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 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems?

ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2017-08-16. The listed applicant is Siemens Healthcare. The 510(k) number is K172162.

When did ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems receive FDA 510(k) clearance?

ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2017-08-16, under 510(k) number K172162.

Who is the listed applicant for ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems?

The FDA 510(k) record lists Siemens Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems?

The FDA product code for ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems 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