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Wuxi Hisky Medical Technologies Co., Ltd.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories3
Latest FDA decision2025-10-01
TypeNumberDevice NameCodeDateActions
510(k) K250026 Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)IYN2025-10-01 View
510(k) K243711 Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);OWN2025-07-24 View
510(k) K243880 Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)IYO2025-06-17 View
510(k) K200136 Shear Wave Quantificational Ultrasound Diagnostic SystemIYO2020-03-17 View
510(k) K173595 Shear Wave Quantificational Ultrasound Diagnostic SystemIYO2018-06-22 View
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