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510(k) Data Aggregation

    K Number
    K251153
    Device Name
    Aurora
    Manufacturer
    GE Medical Systems Israel
    Date Cleared
    2025-06-12

    (59 days)

    Product Code
    KPS, JAK
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Israel

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.
    Device Description
    GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use. Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system.
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    K Number
    K243605
    Device Name
    Aurora
    Manufacturer
    GE Medical Systems Israel, Functional Imaging
    Date Cleared
    2025-01-17

    (57 days)

    Product Code
    KPS, JAK, LLZ
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Israel, Functional Imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures. · NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multi-peak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. · CT System: produces Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications. · NM + CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping (localization, registration, and fusion). The Aurora system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.
    Device Description
    GEHC's Aurora is a SPECT-CT system that combines an all-purpose Nuclear Medicine imaging system and the commercially available Revolution Ascend system. It is intended for general purpose Nuclear Medicine imaging procedures as well as head, whole body, cardiac and vascular CT applications and CT-based corrections and anatomical localization of SPECT images. Aurora does not introduce any new Intended Use. Aurora consists of two back-to-back gantries (i.e. one for the NM sub-system and another for the CT subsystem), patient table, power distribution unit (PDU), operator console with a computer for both the NM acquisition and SmartConsole software and another for the CT software, interconnecting cables, and associated accessories (e.g. NM collimator carts, cardiac trigger monitor, head holder). The CT sub-system main components include the CT gantry, PDU, and CT operator console. All components are from the commercially available GEHC Revolution Ascend CT system. The CT gantry has been adapted for use with predicate device's NM portion. CT PDU, CT Console Keyboard and CT operator console are the same as in Revolution Ascend Plus.
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    K Number
    K241350
    Device Name
    Clarify DL
    Manufacturer
    GE Medical Systems Israel, Functional Imaging
    Date Cleared
    2025-01-03

    (235 days)

    Product Code
    LLZ, KPS
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Israel, Functional Imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clarify DL is a deep learning-based image reconstruction method intended to reduce noise and improve image quality of Nuclear Medicine bone SPECT scintigraphy images. Clarify DL may be used for patients of all ages.
    Device Description
    Clarify DL is a software-only device for the reconstruction of NM bone SPECT scintigraphy images obtained using supported GE HealthCare SPECT and SPECT-CT systems. Clarify DL is designed to reduce image noise while maintaining contrast to enable increased Contrast-to-Noise Ratio (CNR) and Contrast Recovery Coefficient (CRC). Clarify DL is deployed within the software of the predicate Xeleris V Processing and Review System and StarGuide devices.
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    K Number
    K241665
    Device Name
    Omni Legend
    Manufacturer
    GE Medical Systems Israel, Functional Imaging
    Date Cleared
    2024-08-08

    (59 days)

    Product Code
    KPS, JAK
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Israel, Functional Imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GE Omni Legend is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages. Omni Legend is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning. therapy quidance and monitoring. and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion). When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, localization, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are: Cardiology: - · Cardiovascular disease - · Myocardial perfusion - · Myocardial viability - · Cardiac inflammation - · Coronary artery disease Neurology: - · Epilepsy · Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia, and frontotemporal dementia · Movement disorders, such as Parkinson's and Huntington's disease - · Tumors - · Inflammation - · Cerebrovascular disease such as acute stroke, chronic and acute ischemia - · Traumatic Brain Injury (TBI) - Oncology/Cancer: - · Non-Small Cell Lung Cancer - · Small Cell Lung Cancer - · Breast Cancer - · Prostate Cancer - · Hodgkin disease - · Non-Hodgkin lymphoma - · Colorectal Cancer - · Melanoma Omni Legend is also intended for stand-alone, diagnostic CT imaging in accordance with the standalone CT system's cleared indications for use.
    Device Description
    GE HealthCare's subject Omni Legend device, same as the unmodified predicate device, is a hybrid digital PET/CT diagnostic imaging system combining a GEHC Positron Emission Tomography (PET) System and a current production diagnostic GEHC Computed Tomography (CT) System. The proposed Omni Legend is a conventional, general-purpose PET/CT system using existing technological characteristics with identical Intended Use and Indications for Use as its predicate. Omni Legend is made available with a "6 Ring", "4 Ring" configuration of its PET detector that correspondent provide an AFOV of 32 cm, 21cm, 16 cm. Omni Legend's major components include PET gantry / detector, GEHC commercially available Revolution Maxima CT system (K192686), patient table, operator console / workspace, computing hardware, power distribution unit, system software, and image reconstruction software. The operator console and system software control image acquisition and reconstruction, image display and post processing analysis, protocol and patient management, CT dose display, networking, filming, etc.
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    K Number
    K142323
    Device Name
    Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL LTD.
    Date Cleared
    2014-10-10

    (51 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS ISRAEL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) and Transesophageal.
    Device Description
    The Vivid S60/S70 is a Track 3 diagnostic ultrasound system, which is primarily intended for echocardiography imaging and analysis, with additional capability in vascular and general ultrasound imaging. The Vivid S60/S70 incorporates a variety of electronic array transducers that provide digital acquisition, processing and display capabilities, and operate in linear, curved linear, sector/ phased array format or matrix array format, including CW transducer and a real time 3D transducer. Vivid S60/S70 consists of a mobile console approximately 56 cm wide 77 cm deep and 120 cm high, and includes multiple electronic array transducers that provide digital acquisition, processing and display capabilities. The user interface includes a variable height rotatable, user control panel with specialized controls, a 19-inch wide screen LCD display and a separate 12.1-inch touch panel with a resolution of 1280x800 with multi-touch capabilities.
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    K Number
    K102231
    Device Name
    DISCOVERY NM 750B
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Date Cleared
    2010-11-03

    (86 days)

    Product Code
    IYX, PRE
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200keV for the detection and display of radioisotope tracer uptake in patients of all ages.
    Device Description
    The Discovery NM 750b is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. The device may include signal analysis and display equipment, patient and equipment supports, and accessories. The Discovery NM 750b is a high performance and compact planar nuclear imaging system, available in a dual head configuration or a single head configuration. This system is intended to measure and image the distribution of selected single photon emission radioisotopes in the breast and other small body parts in order to aid in the evaluation of lesions.
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    K Number
    K092140
    Device Name
    GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
    Date Cleared
    2009-08-21

    (37 days)

    Product Code
    IYO, ITX, IYN
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; Intraoperative (abdominal, thoracic, and vascular), Intra-cardiac and Intra-luminal.
    Device Description
    The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transducers. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
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    K Number
    K092079
    Device Name
    MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
    Date Cleared
    2009-08-06

    (28 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
    Device Description
    The GE Vivid S6 are mobile ultrasound consoles having a wide assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of autooptimization along with significantly reduced size and weight maneuverable, efficient and easy to use.
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    K Number
    K082374
    Device Name
    VIVID I AND VIVID Q
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD.
    Date Cleared
    2008-09-02

    (15 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; Intraoperative (obdominal, thoracic, and vascular), Intra-cardiac and Inra-luminal.
    Device Description
    The GE Vivid-i and Vivid-q is compact and portable diagnostic ultrasound system with integrated keyboard, fold-up LCD type display and interchangeable electronic-array transancess. It has an overall size approximately 36 cm wide, 31.5 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
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