Chrysalis Intelligence · Sponsors · Wuxi Hisky Medical Technologies Co., Ltd.

Wuxi Hisky Medical Technologies Co., Ltd.

Wuxi, CN · 4 510(k) clearances

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Total clearances
4
2020-03-17 → 2025-10-01
Last 12 months
1
Product codes
3
Most recent
2025-10-01
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYO System, Imaging, Pulsed Echo, Ultrasonic Class II Radiology 2 2025-06-17
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 1 2025-10-01
OWN Confocal Optical Imaging Class II Gastroenterology, Urology 1 2025-07-24
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-10-01 K250026 Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) IYN Class II Radiology
2025-07-24 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); OWN Class II Gastroenterology, Urology
2025-06-17 K243880 Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) IYO Class II Radiology
2020-03-17 K200136 Shear Wave Quantificational Ultrasound Diagnostic System IYO Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence