FDA · official record K173595Substantially Equivalent

Shear Wave Quantificational Ultrasound Diagnostic System

Name: Shear Wave Quantificational Ultrasound Diagnostic System — FDA K173595
Creator: Wuxi Hisky Medical Technologies Co., Ltd.
Keywords: Shear Wave Quantificational Ultrasound Diagnostic System, Shear Wave Quantificational Ultrasound Diagnostic System, K173595, IYO, FDA

United StatesIYOWuxi Hisky Medical Technologies Co., Ltd.

Verified

Official record identity

FDA application number: K173595
Decision date: June 22, 2018
Published decision: Substantially Equivalent

Classification

Product code: IYO

Published parties

Applicant: Wuxi Hisky Medical Technologies Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2017-11-21
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1560

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.