Medical Device Manufacturer · CN , Wuxi

Wuxi Hisky Medical Technologies Co., Ltd.

5 submissions · 5 cleared · Since 2018
5
Total
5
Cleared
0
Denied

Wuxi Hisky Medical Technologies Co., Ltd. — FDA 510(k) Submissions

Wuxi Hisky Medical Technologies Co., Ltd. has submitted 5 FDA 510(k) premarket notifications since 2018, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Imaging, Pulsed Echo, Ultrasonic, Confocal Optical Imaging, System, Imaging, Pulsed Doppler, Ultrasonic . Use the specialty filter in the sidebar to narrow results.

5 devices
1–5 of 5
Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
K250026 · IYN System, Imaging, Pulsed... · Radiology
Oct 2025 268d
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);
K243711 · OWN Confocal Optical Imaging · General & Plastic Surgery
Jul 2025 234d
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
K243880 · IYO System, Imaging, Pulsed... · Radiology
Jun 2025 181d
Shear Wave Quantificational Ultrasound Diagnostic System
K200136 · IYO System, Imaging, Pulsed... · Radiology
Mar 2020 56d
Shear Wave Quantificational Ultrasound Diagnostic System
K173595 · IYO System, Imaging, Pulsed... · Radiology
Jun 2018 213d
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All5 Radiology 4 General & Plastic Surgery 1