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510(k) Data Aggregation
K Number
K230066Device Name
Carnation series Diagnostic Ultrasound System
Manufacturer
Shenzhen Wisonic Medical Technology Co., Ltd.
Date Cleared
2023-09-15
(249 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Wisonic Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Carnation series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It intended for use in Fetal/Obstetrics, abdominal/GYN, pediatrics, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional and superficial), cardiac (adult and pediatric), peripheral vessel, urology, Thoracic/Pleural, Vascular Access exams.
The Camation series Diagnostic Ultrasound System is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals. The clinical environments where the Carnation series can be used include critical care and emergency room environments, as well as point-of care areas in offices, clinical and hospital settings for diagnosis of patients.
Modes of operation include: B-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode.
Device Description
The proposed Carnation series Diagnostic Ultrasound System is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities.
The Carnation series Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power(Dirpower)-Mode, PW Doppler Mode, CW Doppler mode, Holo PW, Tissue Harmonic Imaging, Tissue Doppler Imaging(TDI), Anatomic M-mode(AMM), Color M Mode(CM), Panoramic Imaging(PANO), and combined mode. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.
Holo PW is based on the echo planar imaging, and forms the planar data by emitting and receiving multiple beams to synchronously display the blood flow at multiple sampling gates.
The Carnation series Diagnostic Ultrasound System consists of the main unit, ultrasound probes, ECG lead wire, Magnetic cup, Foot switch, Scanner, USB headset, Camera and Black/white video printer.
The Carnation series Diagnostic Ultrasound System utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Some biopsy kits are available for needle-guidance procedures. The system also includes several automated measurement function: wiCalc_Diaph, wiCalc_Vas, wiCalc_Vol.Flow, Automatic trace, wiCalc_VTI, wiCalc_IVC, wiCalc_IMT, those measurement function can assist users to carry out relevant measurement automatically. The output results of those automatic measurement function are for reference only by users, and the final results need to be confirmed and modified by users based on professional knowledge.
The Carnation series Diagnostic Ultrasound System also include the function of wiScan, wiShow, wiGuide and wiNerve. wiScan is an easy-to-use quality assurance and workflow tool that automatically guides the user through an exam to ensure required steps are performed while reducing key strokes. wiShow is a teaching video recording software, which is an independent functional module integrated in the ultrasound diagnostic system. The function enables doctors to record and edit teaching videos, and export the video to a U disk or network storage. wiGuide uses the characteristics of the magnetic field to enhance the visualization effect of the needle by detecting the magnetized needle, and can better detect the position of the needle when it is in the human body. wiNerve is an education purpose tool, which aims to automatic recognition of different anatomical structures and display the recognized anatomical structures in different colors, to help doctors to improve the skills. The results of wiNerve are not used as diagnostic evidence.
Eight models for the main units are included in this submission, that is Carnation, Carnation Fast, Carnation T, Carnation Exp, Carnation Neo, Carnation+, Carnation Pro, Carnation Ultra. There are thirteen different models of probes: C6-1B-H. C6-2-H, C8-3-H, C9-3-H, EV11-3-H, L15-4WB-H, L15-4NB-H, L15-6-H, L22-10-H, L8-3-H, SP5-1-H, P8-3-H and P12-4-H are available for the Carnation series.
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K Number
K191347Device Name
Paragon XHD Diagnostic Ultrasound System
Manufacturer
Shenzhen Wisonic Medical Technology Co., Ltd.
Date Cleared
2020-02-07
(263 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Wisonic Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diagnostic Ultrasound System is applicable for adults and pediatric patients. It is intended for use in pediatric, small organ (breast, thyroid, testicles, prostate), musculoskeletal (conventional), musculoskeletal (superficial), peripheral vessel and dermatological exams.
Device Description
The Paragon XHD Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. The Paragon XHD Diagnostic Ultrasound System consists of the main unit, an ultrasound probe, power adapter, connecting cable.
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K Number
K182715Device Name
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
Manufacturer
Shenzhen Wisonic Medical Technology Co., Ltd.
Date Cleared
2018-11-20
(54 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Wisonic Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
Device Description
The Piloter Exp/ Piloter P Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, Color Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler, Power/Dirpower mode or the combination of these modes. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.
The Piloter Exp/ Piloter P Diagnostic Ultrasound System consists of the main unit named Piloter series, ultrasound probes, probe extender, power adapter, connecting cable and mobile trolley.
Three models for the main units are included in this submission, that is Piloter Exp. Piloter and Piloter P. there are three different models of probes are available for the Piloter series.
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K Number
K180461Device Name
Navi e/Navi s/Navi X Diagnostic Ultrasound System
Manufacturer
Shenzhen Wisonic Medical Technology Co., Ltd.
Date Cleared
2018-05-09
(78 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Wisonic Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
Device Description
The Navi e/ Navi s/Navi X Diagnostic Ultrasound System is a touch screen controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, and the combined mode. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis. The Navi e/ Navi x/Navi X Diagnostic Ultrasound System consists of the main unit named Navi series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley, ECG module and batteries. Three models for the main units are included in this submission, that is Navi s, Navi e and Navi X. Eight different models of probes are available for the Navi series.
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K Number
K163712Device Name
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System
Manufacturer
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Date Cleared
2018-01-02
(368 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediative patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid, etc.), neonatal cephalic, transcranial, cardiac, transvaginal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
Device Description
The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System is a mobile software controlled ultrasonic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, Color-Mode, Power (Dirpower)-Mode, PW-Mode, CW-mode, and the combined mode. The system can also measure anatomical structures and offer software analysis packages performance to provide information based on which the competent health care professionals can make the diagnosis.
The Clover 50/Clover60/Clover70 Diagnostic Ultrasound System consists of the main unit named clover series, ultrasound probes, power adapter, connecting cable, probe extender, needle-guided bracket, batteries, mobile trolley and travelling case.
Three models for the main units are included in this submission that is Clover 50, Clover 60 and Clover 70. Seven different models of probes are available for the Clover series.
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