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510(k) Data Aggregation
K Number
K240676Device Name
ULTIMUS Series Ultrasound Diagnostic System
Manufacturer
Date Cleared
2024-12-16
(280 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Vinno Technology (Suzhou) Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment.
The systems support the following clinical applications:
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Device Description
The ULTIMUS Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, endocavity, and real time 3D transducer.
The ULTIMUS series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage.
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K Number
K223917Device Name
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
Manufacturer
Date Cleared
2023-06-17
(170 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
VINNO Technology (Suzhou) Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
The operating modes supported by the device are B, M.PWD CWD, Tissue Doppler, Color Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes.
This device is indicated for Abdominal; Fetal; Obstetrics; gynecology;Trans-vagmal; Urology(including prostate); Transrectal; Cardiac(adult and pediatic); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle); Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic diagnostic Ultrasound applications.
This device is intended to use by, or by the order of, and under the supervision of an appropriately-trained healtheare professional qualified to direct the use of the device in hospitals or clinics.
Device Description
VINNO E20, VINNO E10, VINNO E10E, VINNO X1, VINNOX1E, VINNOX1E, VINNO X2, VINNO X2E, VINNO X2E ultrasound devices are professional digital color ultrasonic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.
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K Number
K223920Device Name
VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P
Manufacturer
Date Cleared
2023-06-17
(170 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
VINNO Technology (Suzhou) Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); and Adult Cephalic diagnostic Ultrasound applications.
The operating modes supported by the device are B mode, Harmonic mode, M mode, Color Flow mode, Power-Doppler mode, Pulsed Wave Doppler mode, Continuous Wave Doppler, 3D mode, 4D mode, Spatio Temporal Image Correlation mode, Tissue Doppler mode, Tissue Velocity Imaging mode, Elastography mode and Contrast Agent Imaging mode.
Device Description
The VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、 VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P ultrasound devices are professional digital color ultrasonic diagnostic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.
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K Number
K221911Device Name
VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP
Manufacturer
Date Cleared
2022-12-21
(174 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
VINNO Technology (Suzhou) Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates.
The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, pediatric, musculo-skeletal (conventional, superficial), transrectal, trans-vaginal, cardiac pediatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy).
This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.
The device is used in hospital, clinical point-of-care for diagnosis of patients. The operating modes supported by the device are B, M,PWD CWD, Tissue Doppler, Color M Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, CBI, EI, Combine modes.
Device Description
The VINNO 6EXP, VINNO 6PRO, VINNO 5EXP, VINNO 5PRO, VINNO 3, VINNO 3EXP, VINNO 3PRO ultrasound devices are laptop digital color ultrasonic diagnostic devices which transmit ultrasound waves into the body tissues and display the echo images of the tissues and blood flow accordingly. The devices are capable of digital acquisition, processing and display and operate from an integrated battery or separate power supply/charger.
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