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Found 13 results
510(k) Data Aggregation
K Number
K170870Device Name
Site~Rite Halcyon Diagnostic Ultrasound System
Manufacturer
CHISON Medical Imaging Co., Ltd.
Date Cleared
2017-07-06
(105 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON Medical Imaging Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general-purpose ultrasonic imstrument intended for use by a qualified clinician for evaluation of Fetal/OB, Abdominal (GYN & Urology), Pediatric, Small Organ (breast, testes, thyroid), Cardiac (Adult & Pediatric), Peripheral Vascular, Vascular Access, Musculo-skeletal Conventional & Superficial.
Device Description
The Site -Rite Halcyon device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart.The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery in the docking station , the Site~Rite Halcyon is used primarily where portability, size and convenience are essential.
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K Number
K170374Device Name
SonoBook Series Diagnostic Ultrasound System
Manufacturer
CHISON Medical Imaging Co., Ltd.
Date Cleared
2017-06-06
(119 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON Medical Imaging Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.
Device Description
The SonoBook Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) the image Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
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K Number
K162172Device Name
EBit Series Diagnostic Ultrasound System
Manufacturer
CHISON MEDICAL IMAGING CO., LTD.
Date Cleared
2016-09-14
(42 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON MEDICAL IMAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.
Device Description
The EBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
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K Number
K153085Device Name
Q Series Diagnostic Ultrasound System
Manufacturer
CHISON MEDICAL IMAGING CO., LTD.
Date Cleared
2015-12-21
(56 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON MEDICAL IMAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.
Device Description
The Q Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
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K Number
K150861Device Name
QBit Series Diagnostic Ultrasound System
Manufacturer
CHISON MEDICAL IMAGING CO., LTD.
Date Cleared
2015-07-28
(118 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON MEDICAL IMAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transectal, Transvaginal, Urology.
Device Description
The QBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array . This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.
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K Number
K140364Device Name
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
Manufacturer
CHISON MEDICAL IMAGING CO., LTD.
Date Cleared
2014-06-02
(110 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON MEDICAL IMAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transvaginal.
Device Description
The Q6/Q8/Q9/Q10/i7/i8 /i9 ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured either as a portable model (Q6/Q8/Q9/Q10), or as a roll-around model on wheels (i7/i8/i9). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes.3D/4D.
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K Number
K131305Device Name
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
Manufacturer
CHISON MEDICAL IMAGING CO., LTD.
Date Cleared
2013-08-01
(86 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON MEDICAL IMAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.
Device Description
The ECO Series Diagnostic Ultrasound Systems is a very compact and portable diagnostic ultrasound system having five variations: ECO6, ECO5, ECO3, ECO2, and ECO1, each with options and features suited for its market niche. It has an integrated keyboard, LED display and several interchangeable electronic-array transducers and provides digital acquisition, processing and display capability. The user interface includes a keyboard, an intuitive layout of specialized controls, color GUI display.
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K Number
K121867Device Name
SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
Manufacturer
CHISON MEDICAL IMAGING CO., LTD.
Date Cleared
2012-08-02
(37 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON MEDICAL IMAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ(breast, testes, thyroid); Cardiac (adult & pediatric); Peripheral Vascular, Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal.
Device Description
The SonoTouch Series device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is graphical user interface implemented by a touch sensitive screen over the color LED display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes. with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply in the docking station or docking cart, the SonoTouch Series is used primarily where portability, size and convenience are essential.
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K Number
K120801Device Name
CHISON DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
CHISON MEDICAL IMAGING CO., LTD.
Date Cleared
2012-06-14
(90 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON MEDICAL IMAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for the evaluation of Fetal (Obstetrics), Abdomen, Cardiac (Adult, Pediatric), Small Organ (Thyroid, testes and breast etc), Peripheral Vascular, Transvaginal, Musculo-skeletal (Conventional and Superficial), Pediatric, OB/Gyn and Urology.
Device Description
The CHISON Q6 / Q8 / iVis60 / iVis60 / EXPERT / i7 ultrasound system is an integrated preprogrammed color Doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured either as a portable model (Q6/Q8), or as a roll-around model on wheels (iVis60 / iVis60 EXPERT/i7). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.
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K Number
K113359Device Name
CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
Manufacturer
CHISON MEDICAL IMAGING CO., LTD.
Date Cleared
2012-02-03
(81 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
CHISON MEDICAL IMAGING CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The system is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parotid, submaxillary gland, testes and breast.). Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
Device Description
The CHISON iVis20/iVis30/i3/ Q1/Q2/Q3/Q5 ultrasound system is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The CHISON ultrasound system can be configured as a roll-around model on wheels (iVis20/iVis30/i3/ Q1/Q2/Q3/Q5). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems which have been available in the market for years. This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, or a combination of these modes.
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