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510(k) Data Aggregation

    K Number
    K121758
    Device Name
    CERNER FETALINK+(VERSION1.0)
    Manufacturer
    CERNER CORP.
    Date Cleared
    2012-10-09

    (116 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERNER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cerner FetaLink+ is a software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms in one view. FetaLink+transforms the ongoing measurements into a visual wave display which conveys the frequency, duration and relative strength of uterine contractions combined with the patient data of pregnant women in the antepartum and/or intrapartum phases of pregnancy.
    Device Description
    Cerner FetaLink+ is the software application that runs on the user's iPhone or iPad. The application displays patient clinical waveform data including maternal heart rates, maternal oxygen saturation, maternal blood pressure, and uterine contractions. Within the application, the user can view annotations associated to waveform data.
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    K Number
    K093134
    Device Name
    CERNER CAREAWARE IBUS
    Manufacturer
    CERNER CORP.
    Date Cleared
    2009-11-27

    (53 days)

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

    CERNER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cerner iBus is a software application intended for use in the transportation, aggregation and derivation of data between medical devices and external systems used in a clinical setting for the purpose of automating data collection and clinical information management. Cerner iBus is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Cerner iBus come into direct contact with patients.
    Device Description
    Not Found
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    K Number
    K091251
    Device Name
    CERNER FETALINK (VERSION 1.0)
    Manufacturer
    CERNER CORP.
    Date Cleared
    2009-08-25

    (118 days)

    Product Code
    HGM
    Regulation Number
    884.2740
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERNER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.
    Device Description
    Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.
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    K Number
    K091032
    Device Name
    CERNER PROVISION WORKSTATION (VERSION 2.5)
    Manufacturer
    CERNER CORP.
    Date Cleared
    2009-06-22

    (73 days)

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

    CERNER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K070394
    Device Name
    CERNER PROVISION WORKSTATION
    Manufacturer
    CERNER CORP.
    Date Cleared
    2007-03-27

    (46 days)

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

    CERNER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cerner ProVision Workstation is a software application intended for the rendering. visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists. Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review. The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
    Device Description
    Not Found
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    K Number
    K000770
    Device Name
    PROVIEW MEDICAL IMAGE DISPLAY MODULE
    Manufacturer
    CERNER CORP.
    Date Cleared
    2000-05-16

    (68 days)

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

    CERNER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955000
    Device Name
    REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
    Manufacturer
    CERNER CORP.
    Date Cleared
    1996-01-26

    (86 days)

    Product Code
    LMD
    Regulation Number
    892.2020
    Why did this record match?
    Applicant Name (Manufacturer) :

    CERNER CORP.

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