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United States FDA 510(k) clearance K173595Substantially Equivalent

Shear Wave Quantificational Ultrasound Diagnostic System

United StatesClass 2Wuxi Hisky Medical Technologies Co., Ltd.Cleared Jun 22, 2018
Verified
Clearance details
K-Number
K173595
View FDA 510(k) Summary PDF View on FDA Database
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Product Code
IYO
View Product Code Classification
Device Class
Class 2
Clearance Type
Traditional
Regulation Number
892.1560
View CFR Regulation
Applicant information
Applicant
Wuxi Hisky Medical Technologies Co., Ltd.
Contact
Jinhua Shao
Location
Rm. B401, 530 Plz., University Science Park, Taihu Internati
Wuxi 214135
CN
Medical classification
Medical Specialty
Radiology
Advisory Committee
RA
Dates and decision
Date Received
Nov 21, 2017
Decision Date
Jun 22, 2018
Decision
Substantially Equivalent
Statement / Summary

Summary

About this record

Access comprehensive regulatory information for Shear Wave Quantificational Ultrasound Diagnostic System in the USA medical device market through Pure Global AI's free database. This Class 2 medical device was cleared under FDA 510(k) number K173595 and submitted by Wuxi Hisky Medical Technologies Co., Ltd.. The clearance decision was Substantially Equivalent on Jun 22, 2018.

This page provides complete clearance details including product code IYO, medical specialty classification (Radiology), and regulatory compliance information from the official FDA OpenFDA database. Pure Global AI offers free access to FDA 510(k) clearances from 1976 to present, helping global MedTech companies navigate USA FDA regulations efficiently.