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United States FDA 510(k) clearance K250026Substantially Equivalent

Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)

United StatesClass 2Wuxi Hisky Medical Technologies Co., Ltd.Cleared Oct 01, 2025
Verified
Clearance details
K-Number
K250026
View FDA 510(k) Summary PDF View on FDA Database
Note: PDF may not be available for all submissions
Product Code
IYN
View Product Code Classification
Device Class
Class 2
Clearance Type
Traditional
Regulation Number
892.1550
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
Jan 06, 2025
Decision Date
Oct 01, 2025
Decision
Substantially Equivalent
Statement / Summary

Summary

About this record

Access comprehensive regulatory information for Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) 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 K250026 and submitted by Wuxi Hisky Medical Technologies Co., Ltd.. The clearance decision was Substantially Equivalent on Oct 01, 2025.

This page provides complete clearance details including product code IYN, 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.