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510(k) Data Aggregation

    K Number
    K211046
    Device Name
    eCareManager 4.5
    Manufacturer
    Visicu, Inc.
    Date Cleared
    2022-06-03

    (421 days)

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

    Visicu, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use Statement: The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems connected through networks. Using this data, clinical decisions are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. Indications for Use Statement: The eCareManager software is solely indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
    Device Description
    The eCareManager System is a collection of software applications designed to facilitate the delivery of high-quality critical care services with the assistance of a Telehealth Center Program (THC). The THC provides an organizational and technology platform to transform critical care by redesigning the way critical care is structured and managed. The THC Care Team is a multi-professional team that includes both bedside and THC remote clinicians working together to ensure the best care is provided. The eCareManager System provides a robust toolset that helps ICU and Acute Care clinicians plan, document, and standardize care around best practices. Population management and communications facilitate a collaborative approach to delivery of in-patient care. The system's clinical decision support applications further aid in the proactive delivery of care. Using data received from the hospital's systems, clinical decision support algorithms provide cues that assist in the early detection of changes in patient condition.
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    K Number
    K171322
    Device Name
    eCareManager 4.1
    Manufacturer
    Visicu, Inc.
    Date Cleared
    2017-08-03

    (90 days)

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

    Visicu, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use Statement: The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. Indications for Use Statement: The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
    Device Description
    The eCareManager system is a software platform that enables enterprise telehealth. The system includes interface features to acquire patient data from the electronic medical record and bedside devices which can be shared between the bedside and remote care teams. Population management and communication features facilitate a collaborative approach to delivery of in-patient care. The system's clinical decision support features further aid in the proactive delivery of care. Using data received from the hospital's systems, clinical decision support algorithms provide cues that assist in the early detection of changes in patient condition.
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    K Number
    K153156
    Device Name
    eCareManager 4.0.1
    Manufacturer
    VISICU, INC.
    Date Cleared
    2016-09-30

    (333 days)

    Product Code
    MSX, NSX, OUG, PLB
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISICU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use Statement: The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems and ancillary systems connected through networks. Using this data, clinical decision support notifications are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians. All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making. Indications for Use Statement: The eCareManager software is indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
    Device Description
    The eCareManager (eCM) system is a software platform that enables enterprise telehealth. The system includes an interface to acquire patient data from the electronic medical record and bedside devices. eCM provides a history of the patient population in clinic and provides a clinical decision support feature to aid in the proactive delivery of consultative care for the patient
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    K Number
    K141706
    Device Name
    ECARE COORDINATOR (ECC)
    Manufacturer
    VISICU, INC.
    Date Cleared
    2014-09-09

    (77 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISICU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.
    Device Description
    eCareCoordinator (eCC) is a software-only telemedicine system. eCareCoordinator (eCC) is a combination of technology and clinical programs designed to enable the support of patients in the home setting, eCC is intended to support the clinician with monitoring of remote patients. Clinicians use eCC to manage populations of ambulatory care patients, while keeping primary care physicians informed of patient status. eCC is comprised of the following primary components: - . eCareCoordinator (eCC): eCC is the platform supporting the Clinical User Interface. eCC is a cloud-based system, which is used to acquire patient data from home devices, as well as provide a population management triage dashboard to enable the clinician's team to prioritize and manage populations of patients. - . eCareCompanion (eCP): eCP is a patient application element of eCareCoordinator used to engage patients in their own health. eCP is a mobile application which runs on an commercial off-the-shelf (COTS) Android tablet. Patients manually input measurements (including weight, blood pressure, pulse, blood glucose concentration, SpO2, temperature, prothrombin time (PT), coagulation ratio (INR), and transthoracic impedance) from measurement devices into the COTS tablet containing eCP. The COTS tablet wirelessly communicates with eCC to transmit the data stored by eCP to eCC.
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    K Number
    K012171
    Device Name
    MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
    Manufacturer
    VISICU, INC.
    Date Cleared
    2001-07-24

    (12 days)

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

    VISICU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VISICU ARGUS System is intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. The VISICU ARGUS System is intended to provide patient information and surveillance of monitored patients at the point of care location and at a remote supplementary care location through wide area networking technology and dedicated telephone lines. The VISICU ARGUS System is solely intended for use in a hospital environment. It is not intended to be used in a home environment.
    Device Description
    Not Found
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    K Number
    K001972
    Device Name
    ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK
    Manufacturer
    VISICU, INC.
    Date Cleared
    2000-10-27

    (121 days)

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

    VISICU, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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