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510(k) Data Aggregation

    K Number
    K240087
    Device Name
    RT Carbon ECG Leads
    Date Cleared
    2024-09-13

    (246 days)

    Product Code
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ivy Biomedical Systems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ivy Biomedical RT Carbon ECG Leads are intended for use in X-ray imaging environments. They connect between ECG electrodes that are placed on the patient by a trained healthcare professional and an ECC trunk cable that connects to the ECG monitoring device. The RT Carbon ECG Leads are reusable and nonsterile. The RT Carbon ECG Leads are intended for adult, pediatric and neonatal patient populations.
    Device Description
    The RT Carbon ECG Leads are intended to connect electrodes placed on the patient to a physiological detection module or monitor (CTM-300, CTM-400, CTM-500, 7000 Series and 3000 Series). The design includes 3 and 4 lead designs with overall lengths of 24", 30" and 36".
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    K Number
    K202138
    Device Name
    Cardiac Trigger Monitor
    Date Cleared
    2021-05-14

    (287 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ivy Biomedical Systems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ivy Biomedical Model 7600EP/7800EP is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization, such as nuclear medicine, computed axial (CAT), or positron emission (PET) tomography and other imaging systems requiring similar cardiac cycle specific timing. The Ivy Biomedical Model 7600EP/7800EP monitors can also be used to provide cardiac trigger pulse output used by a third-party ablation and lithotripsy systems.
    Device Description
    Not Found
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    K Number
    K203653
    Device Name
    MRI PPG Patient Cable
    Date Cleared
    2021-03-02

    (77 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ivy Biomedical Systems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MRI PPG Patient Cable is intended to connect to a parent device and facilitate the generation of continuous noninvasive peripheral pulse cardiac gating on adult, pediatric, and neonatal patients in hospital and/or health care environments.
    Device Description
    Not Found
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    K Number
    K192852
    Device Name
    MRI ECG Patient Cable
    Date Cleared
    2020-03-28

    (177 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ivy Biomedical Systems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MRI ECG Patient Cable is intended to connect electrodes placed on a patient to a host device. The cable is intended for use in up to 3.0T in MRI environments. It is used in a professional healthcare facility environment.
    Device Description
    Not Found
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    K Number
    K171778
    Device Name
    MR Wireless Gating System, Model WGS-100
    Date Cleared
    2018-03-14

    (272 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ivy Biomedical Systems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ivy MR Wireless Gating System's intended use is to acquire physiologic signals, comprising ECG, PP, and RESP, to provide reference outputs to trigger the acquisition of gated images during MRI scanning in systems operating at 3.0 Tesla in strength. The MR Wireless Gating System is intended for use on adult and pediatric patients. This product is limited to use by trained and qualified medical professionals. This product is not intended for the diagnosis, treatment, or prevention of any disease nor is it intended as life support equipment. The product is restricted for use on one patient at a time and is not in home care monitoring. This product not intended to provide diagnostic clinical information with regard to patient cardiac, peripheral pulse, or respiratory monitoring. The Ivy MR Wireless Gating System is to be used in conjunction with GE Healthcare Signa Premier 3T Magnetic Resonance Scanners.
    Device Description
    Not Found
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    K Number
    K170828
    Device Name
    Cardiac Trigger Monitor
    Date Cleared
    2017-05-17

    (58 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ivy Biomedical Systems, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization. The Model 7600/7800 is intended for use in neonatal, pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals. The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.
    Device Description
    The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization.
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    K Number
    K110987
    Device Name
    CARDIAC TRIGGER MONITOR
    Date Cleared
    2011-07-22

    (105 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVY BIOMEDICAL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization. The Model 7600 is limited to use by trained and qualified medical professionals. This product is not intended for home care monitoring.
    Device Description
    The Ivy Biomedical Model 7600 Cardiac Trigger Monitor is a simple to use instrument for monitoring the ECG and Heart Rate. It is designed for use in the ICU, CCU and operating room conditions. It can sound an alarm when the HR falls outside of preset limits. It provides an output pulse, synchronized to the R-wave for use in applications requiring precision R-wave synchronization.
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    K Number
    K091787
    Device Name
    MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
    Date Cleared
    2009-10-09

    (114 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVY BIOMEDICAL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Model 6000 is intended to provide continuous noninvasive monitoring of SpO2 and EtCO2 indications. The parameters are derived from both the measurements of arterial oxygen hemoglobin saturation and pulse rates as well as relative expired and inspired CO2 levels. The recorded data may be displayed locally and also transmitted wirelessly to any device supporting the 802.11 communication protocol. This device is intended for use on adult, geriatric, and neonatal patients in bedside or mobile applications within health care institutions and/or health care environments only under the direction of a physician or qualified clinician.
    Device Description
    The device is a two parameter patient monitor. Both EtCO2 and SpO2 parameters are derived from commercially available modules that are incorporated internally. The device displays the waveforms and numerical values associated with each parameter on a color LCD display, and transmits the information to a network based computing device over the 802.11a - g IEEE wireless protocol. The device is intended for use on adult, geriatric, pediatric, and neonatal patients only under the direction of a physician or qualified clinician.
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    K Number
    K091985
    Device Name
    UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
    Date Cleared
    2009-07-24

    (22 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVY BIOMEDICAL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Universal Physiological Measurement Module is intended for use on patients requiring Rwave synchronization and timed imaging studies. Applications include: gamma cameras, TMR/PMR, multislice CT, PET/CT, and SPECT/CT. The UPMM is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.
    Device Description
    Universal Physiological Measurement Module (UPMM)
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    K Number
    K083854
    Device Name
    CARDIAC TRIGGER, MODEL: CTM300
    Date Cleared
    2009-02-13

    (51 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVY BIOMEDICAL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cardiac Trigger Module model CTM-300 is intended for use on patients requiring Rwave synchronization and timed imaging studies. Applications include: gamma cameras, TMR/PMR, multislice CT, PET/CT and SPECT/CT. The CTM-300 is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.
    Device Description
    The Cardiac Trigger Module model CTM-300 is responsible for detecting the patient's heart waveform and producing a synchronized pulse that is used to trigger a device.
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