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510(k) Data Aggregation
K Number
K251322Device Name
Venue; Venue Go; Venue Fit; Venue Sprint
Manufacturer
GE Medical Systems Ultrasound and Primary care Diagnostics,
Date Cleared
2025-07-25
(87 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K233692Device Name
Voluson Signature 20, Voluson Signature 18
Manufacturer
GE Medical Systems Ultrasound and Primary care Diagnostics,
Date Cleared
2024-03-07
(111 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Voluson Signature 18 / Voluson Signature 20 system are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson Signature 18 / Voluson Signature 20 system clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic: Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shearwave Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/ PWD, B/Power/PWD. The Voluson Signature 18 / Voluson Signature 20 system are intended to be used in a hospital or medical clinic.
Device Description
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
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K Number
K232381Device Name
LOGIQ Totus
Manufacturer
GE Medical Systems Ultrasound and Primary care Diagnostics,
Date Cleared
2023-12-07
(121 days)
Product Code
IYN, ITX, IYO, QIH
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LOGIQ Totus is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. LOGIQ Totus clinical applications include: Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac(Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal.
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging, Contrast Enhanced Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
The system is intended to be used in Hospital or Clinical environments such as Intensive Care Unit(ICU, CVICU, CCU), Neonatal Intensive Care Unit(NICU), Pediatric Intensive Care Unit(PICU), Emergency Room, Operating Room, Outpatient Surgery Clinic, Radiology, Medical Office (Nurse Practitioner), Observational Units, Cath Lab, Clinic, Physician's Office, Labor/Deliver Unit and Oncology.
Device Description
The LOGIQ Totus is full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 490mm wide(monitor width: 545mm), 835mm deep and 1415~1815mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls. 14-inch LCD touch screen and color 23.8-inch LCD & HDU image display.
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K Number
K231966Device Name
LOGIQ E10
Manufacturer
GE Medical Systems Ultrasound and Primary care Diagnostics,
Date Cleared
2023-11-07
(127 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LOGIQ E10 is intended for use by a qualified physician for ultrasound evaluation of Fetal / Obstetrics; Abdominal (including Renal, Gynecology/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including Prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (Abdominal and Vascular).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ E10 is intended to be used in a hospital or medical clinic.
Device Description
The LOGIQ E10 is a full featured, track 3, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 991 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch highresolution color touch screen and 23.8-inch High Contrast LED LCD monitor.
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K Number
K231965Device Name
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Date Cleared
2023-10-30
(119 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.
Device Description
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
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K Number
K223407Device Name
Versana Essential
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Date Cleared
2023-02-15
(98 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Versana Essential is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Essential clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, VascularPeripheral Vascular, Musculoskeletal Conventional, Musculosketal Superficial, Thoracic/Pleural, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access).
Modes of operation include: B. M. PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD, B Flow/B Flow Color.
Versana Essential is intended to be used in a hospital or medical clinic.
Device Description
The Versana Essential is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers.
The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source.
The operator control panel includes function keys, trackball, an alfa-numeric keyboard.
The variety of transducers include convex, linear, sector, and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.
Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port. The Video adapter is optional part which used to extend the S-Video/Composite Out interface by connecting with HDMI port. The system has a DC outlet to allow connection of a DC printer which sits in the printer box of the console and an option for external Printer USB Isolator for other commercial printers to connect.
The system allows for electronic instructions for use and software updates to be download from a GE Healthcare website.
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K Number
K220940Device Name
EchoPAC Software Only, EchoPAC Plug-in
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Date Cleared
2022-07-22
(113 days)
Product Code
QIH, LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic,3D, and Real time (RT) 3D Mode (4D).
Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV): Intraoperative ( vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.
Device Description
EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.
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K Number
K221147Device Name
Vivid T8, Vivid T9
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Date Cleared
2022-07-18
(89 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Ceplalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculosketal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Device Description
Vivid T9/Vivid T8 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.
The Vivid T9/Vivid T8 consists of a mobile console with control panel color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, and dual array including dedicated CW transducers.
The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alpha-numeric keyboard.
The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.
The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.
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K Number
K220619Device Name
Vivid S60N, Vivid S70N
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Date Cleared
2022-07-15
(134 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vivid S60N/Vivid S70N is a general-purpose ultrasound system, specialized for use in cardiac imaging. 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 hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal, Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural, and Intraoperative (vascular). Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD or CWD, B/ Color/PWD or CWD, B/Power/PWD.
Device Description
Vivid S60N / Vivid S70N is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.
The Vivid S60N / Vivid S70N consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducer. System can also be used with compatible ICE transducers.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USBadapter) connection.
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K Number
K220358Device Name
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
Manufacturer
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Date Cleared
2022-06-06
(118 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
GE Medical Systems Ultrasound and Primary Care Diagnostics,
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal
Modes of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, Power Doppier, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/ PWD, B/Elastography. The Voluson™ Expert 20, Voluson™ Expert 22 is intended to be used in a hospital or medical clinic.
Device Description
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
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