Class Class II

Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) (K250026)

K250026 2025-10-01 Traditional
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Description

Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) by Wuxi Hisky Medical Technologies Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250026
Clearance Date2025-10-01
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

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