WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.

FDA Device Registration & Listing · Wuxi Jiangsu, CN · Registration 3016493665

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3016493665
FEI Number
3016493665
Entity Name
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
City/State/Country
Wuxi Jiangsu, CN
Establishment Address
Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi,, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA, Wuxi Jiangsu 214135, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Wuxi Hisky Medical Technologies Co., Ltd. (Owner Number: 10062500)
Owner / Operator Contact Address
Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park, 214135 Wuxi,, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA, Wuxi, CN-JS 214135, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Confocal Microprobe Imaging System iLivTouch iLivTouch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2025-08-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2020-03-31
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-03-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2020-03-31
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-11-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-11-20
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-11-20
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2025-08-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2025-08-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2025-08-03

Official Correspondent

Ying Duan

US Agent Details

Vincent Zhou Business: Medwheat Inc Email: vincent.zhou@medwheat.com Phone: (612) 8062995

Related Public Records

Same Entity

Wuxi Hisky Medical Technologies Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260108 Stryker Endoscopy L12 LED Light Source with AIM 2026-02-12
K191144 Mauna Kea Technologies Cellvizio 100 Series System with Confocal Miniprobes 2020-01-24
K243591 Optosurgical, LLC OPTOVISION Endoscopic Light Source Unit 2025-02-19
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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8010047 OLYMPUS MEDICAL SYSTEMS CORP. HACHIOJI-SHI Tokyo, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016493665. Last updated year: 2026. Please use registration number 3016493665 when referencing this establishment in official correspondence.
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