FDA 510(k)

ACUSON SC2000诊断超声系统

K号: K162221 · 2016-09-06

申请人Siemens Medical Solutions Inc. Ultrasound Group

决定日期2016-09-06

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

ACUSON SC2000 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions Inc. Ultrasound Group. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K162221. 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 SC2000 Diagnostic Ultrasound System?

ACUSON SC2000 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Siemens Medical Solutions Inc. Ultrasound Group. The 510(k) number is K162221.

When did ACUSON SC2000 Diagnostic Ultrasound System receive FDA 510(k) clearance?

ACUSON SC2000 Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-09-06, under 510(k) number K162221.

Who is the listed applicant for ACUSON SC2000 Diagnostic Ultrasound System?

The FDA 510(k) record lists Siemens Medical Solutions Inc. Ultrasound Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON SC2000 Diagnostic Ultrasound System?

The FDA product code for ACUSON SC2000 Diagnostic Ultrasound System is IYN.

相关器械（代码：IYN）

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器械摘要

常见问题

相关临床试验

相关器械（代码：IYN）

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