FDA 510(k)

InnoSight 诊断超声系统

K号: K172056 · 2017-12-13

决定日期2017-12-13

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

InnoSight Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Qisda Corporation. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K172056. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InnoSight Diagnostic Ultrasound System?

InnoSight Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Qisda Corporation. The 510(k) number is K172056.

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

InnoSight Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-12-13, under 510(k) number K172056.

Who is the listed applicant for InnoSight Diagnostic Ultrasound System?

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

What is the FDA product code for InnoSight Diagnostic Ultrasound System?

The FDA product code for InnoSight Diagnostic Ultrasound System is IYO.

列明Qisda Corporation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。

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官方来源

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