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510(k) Data Aggregation

    K Number
    K152749
    Device Name
    moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager
    Manufacturer
    Moor Instruments Ltd
    Date Cleared
    2016-05-12

    (232 days)

    Product Code
    DPT, GEX
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Moor Instruments Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorLDI2 Laser Doppler Imager is intended for blood flow measurements in the microcirculation. It is intended to be used for clinical research applications and pre-clinical research applications.
    Device Description
    The moorLDI2 is a device to perform non-invasive blood flow measurements in the microcirculation, for example skin, using the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. The system scans a very low power laser beam across the tissue. Moving blood in the microvasculature causes a Doppler frequency shift of the laser light, which is photo detected and processed to generate a colour coded blood flow map, line by line. An in built CCD camera records a colour photograph to aid visualisation of the scan site.
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    K Number
    K132163
    Device Name
    MOORLDLS-BI LASER DOPPLER BURNS IMAGER
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2014-01-29

    (201 days)

    Product Code
    DPT, GEX
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorLDLS-BI laser Doppler burns imager assesses the blood flow in burn wounds of the skin, when cleaned of surface debris, to aid in the clinician's assessment of burn wound healing potential. It is intended to be used as an aid to burn wound management for patients with Total Body Surface Area burn of up to 30%. The device is intended to be used as an aid to burn wound assessment, and not as a stand-alone prediction device.
    Device Description
    The moor DLS-BI laser Doppler burns imager is an imaging device to aid the clinician to judge the healing potential of bums and the need for surgery. It uses the laser Doppler imaging technique to quantify the blood flow in an area of skin damaged by a burn. The device uses a line of laser light projected onto the tissue and a linear detector arrav that sample from the line as it is swept across the tissue to rapidly build up a colour coded image of blood flow in the burn area and the surrounding normal skin for healing potential prediction. In addition, a CCD camera is integrated into the scanner unit for recording a colour photograph at the time of scanning, corresponding closely with the blood flow image in size and aspect.
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    K Number
    K122943
    Device Name
    MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2013-01-03

    (101 days)

    Product Code
    DPT
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorFLPI-2 Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.
    Device Description
    The moorFLPI-2 is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using speckle contrast analysis. The tissue surface is illuminated with a diverging infra-red laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate colour coded images of the tissue blood perfusion in the microcirculation.
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    K Number
    K112826
    Device Name
    NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2012-10-10

    (378 days)

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

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorVMS-OXY monitor is a non-invasive monitoring system that measures tissue oxygen saturation and tissue temperature in microcirculation. It is intended to noninvasively and continuously measure approximated value of hemoglobin oxygen saturation in superficial tissues for clinical research applications. The clinical value of measurements in disease states has not been demonstrated. The moorVMS-OXY monitor should not be used as the sole basis for diagnosis or therapy. The moorVMS-OXY monitor can also be used for the simultaneous measurement of tissue oxygen saturation and blood flow in microcirculation using a combined probe in conjunction with a moorVMS-LDF laser Doppler blood flow monitor.
    Device Description
    The moorVMS-OXY is a device for taking non-invasive measurements of tissue hemoglobin (oxy-Hb and deoxy-Hb) and oxygen saturation (SO2), together with tissue temperature. It is based on the theory of while-light reflectance spectroscopy and its measurement relies on spectrophotometric principles that relate light absorption to chromophore concentrations. Measurements are taken using probes which are placed with the tissue at the measurement site. Optical fibres are used to deliver illumination light to the tissue and collect reflectance light to the instrument for processing. The moorVMS-OXY™ analyses the back scattered reflected light in the wavelength range of 500 to 650nm and calculates tissue oxygenation by matching the collected spectra to the absorption curves from known concentrations of oxygenated / deoxygenated hemoglobin. This is to allow a rapid and accurate measurement of oxygenation saturation SO2(%), total hemoglobin and oxygenated hemoglobin levels in the sample volume. When used in conjunction with a moorVMS-LDF laser Doppler blood flow monitor, the moorVMS-OXY can also be used for the simultaneous measurement of tissue oxygen saturation and blood flow in microcirculation using a combined probe.
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    K Number
    K102433
    Device Name
    MOORVMS-PRES PRESSURE CUFF CONTROLLER
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2010-11-18

    (84 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorVMS-PRES pressure cuff controller is a device for cuff inflation and deflation control and pressure measurement. It is intended to allow non-invasive measurement of skin perfusion pressure, pulse volume, systolic blood pressure and ankle/toe brachial pressure index when used with a laser Doppler monitor either manually by the operator or automatically by separate dedicated PC software.
    Device Description
    The moorVMS-PRES vascular assessment pressure cuff controller is a device for cuff inflation and deflation control and pressure measurement. It allows connection of a range of standard pressure cuffs, ranging in size from small digit cuffs. It incorporates an air pump for cuff inflation and a proportional valve for controlled deflation. The moorVMS-PRES provides measurement of cuff gauge pressure which can be displayed on the front panel, and also the AC component of the cuff pressure (referred to as pulse volume) which can be outputted as analogue signals via a BNC connector or as digital data via the USB port. The moorVMS-PRES is capable of performing timed inflation/deflation sequences when used alone and also be capable of remote control when connected to a PC via USB. The moorVMS-PRES is intended to form part of a modular vascular monitoring system when used in conjunction with the moorVMS-LDF laser Doppler perfusion and temperature monitors. When used in this way the instruments will be controlled and monitored via USB using PC software to perform vascular assessment such as Skin Perfusion Pressure (SPP), Limb Blood Pressure or Toe Blood Pressure (LBP/TBP), Pulse Volume (PV), and Post Occlusive Reactive Hyperemia (PORH) analyses.
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    K Number
    K083082
    Device Name
    MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2009-01-13

    (89 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorVMS-LDF1 and moorVMSLDF2 laser Doppler perfusion and temperature monitors are intended for simultaneous measurement of tissue temperature and blood flow in the microcirculation. The devices are intended for clinical research use.
    Device Description
    moorVMS-LDF1 Laser Doppler perfusion and temperature monitor moorVMS-LDF2 Laser Doppler perfusion and temperature monitor
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    K Number
    K060976
    Device Name
    MOORLD12-B1 LASER DOPPLER BURNS IMAGER
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2007-03-27

    (351 days)

    Product Code
    DPT, GEX
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorLDI2-BI laser Doppler burns imager assesses the blood flow in debrided burn wounds of the skin. It is intended to be used as an aid to burn wound management for patients with Total Body Surface Area burn of up to 30%.
    Device Description
    The moorLDI2-BI laser Doppler imager is a measurement device to aid the clinician judge the healing potential of burns and the need for surgery. It uses the laser Doppler technique to quantify the blood flow in an area of skin damaged by a burn. The device has the means to scan a low power visible red laser beam or low power near infrared laser beam combined with a visible red target beam, across the skin surface enabling a colour coded image of the blood flow in the burn area and the surrounding normal skin to be recorded, together with a monochrome photo image. In addition, a colour video image of the scanned area is recorded using a CCD camera which is an integral part of the device. Regions of interest (e.g. a burn area) can be selected and the statistics of the blood flow values, within the region, calculated and displayed.
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    K Number
    K063586
    Device Name
    MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2007-01-25

    (55 days)

    Product Code
    DPT, GEX
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorFLPI Full-Field Laser Perfusion Imager is intended for blood flow measurements in the microcirculation. This device is intended for clinical research use.
    Device Description
    The moorFLPI is a device to perform non-contact imaging of tissue blood perfusion in the microcirculation, for example skin, using speckle contrast analysis. The tissue surface is illuminated with a diverging infra-red laser beam resulting in a laser speckle pattern. The pattern is imaged by a CCD camera and image processing of the speckle contrast is used to generate colour code images of the tissue blood perfusion in the microcirculation.
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    K Number
    K063561
    Device Name
    MOORLDLS LASER DOPPLER LINE SCANNER
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2007-01-19

    (53 days)

    Product Code
    DPT
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorLDLS Laser Doppler Line Scanner is intended for blood flow measurements in the microcirculation.
    Device Description
    The moorLDLS laser Doppler line scanner is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the predicate device moorLDI2-IR laser Doppler imager, which use a single low power infrared laser beam, the moorLDLS line scanner sweeps a line of laser light across the tissue to build up a colour coded image of blood flow rapidly.
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    K Number
    K032841
    Device Name
    MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
    Manufacturer
    MOOR INSTRUMENTS LTD.
    Date Cleared
    2003-12-10

    (90 days)

    Product Code
    DPT, GEX
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    MOOR INSTRUMENTS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The moorLDI2-IR infrared laser Doppler Imager is intended for blood flow measurements in the microcirculation.
    Device Description
    The moorLD12-IR infrared laser Doppler imager is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the existing MK1 moorLDI laser Doppler imager, which use a low power visible red HeNe laser, the moorLDI2-IR has a low power infrared laser beam combined with a visible target beam to scan in a raster pattern over the skin surface to build up a colour coded image of blood flow.
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