K243880

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)

510(k) number: K243880
Device name: Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
Applicant: Wuxi Hisky Medical Technologies Co., Ltd. CN
Product code: IYO — System, Imaging, Pulsed Echo, Ultrasonic
Decision date: 2025-06-17
Date received: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Radiology

Also available from FDA: K243880.pdf

Official FDA record: K243880

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.