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United States FDA 510(k) clearance K200136Substantially Equivalent

Shear Wave Quantificational Ultrasound Diagnostic System

United StatesClass 2Wuxi Hisky Medical Technologies Co., Ltd.Cleared Mar 17, 2020
Verified
Clearance details
K-Number
K200136
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
B401, 530 Plz., University Science Park,
Taihu International Science & Tech.
Wuxi 214135
CN
Medical classification
Medical Specialty
Radiology
Advisory Committee
RA
Dates and decision
Date Received
Jan 21, 2020
Decision Date
Mar 17, 2020
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 K200136 and submitted by Wuxi Hisky Medical Technologies Co., Ltd.. The clearance decision was Substantially Equivalent on Mar 17, 2020.

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.