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Found 12 results
510(k) Data Aggregation
K Number
K152749Device 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
870.2120Why 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
K132163Device Name
MOORLDLS-BI LASER DOPPLER BURNS IMAGER
Manufacturer
MOOR INSTRUMENTS LTD.
Date Cleared
2014-01-29
(201 days)
Product Code
DPT, GEX
Regulation Number
870.2120Why 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
K122943Device Name
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
Manufacturer
MOOR INSTRUMENTS LTD.
Date Cleared
2013-01-03
(101 days)
Product Code
DPT
Regulation Number
870.2120Why 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
K112826Device Name
NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
Manufacturer
MOOR INSTRUMENTS LTD.
Date Cleared
2012-10-10
(378 days)
Product Code
MUD
Regulation Number
870.2700Why 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
K102433Device Name
MOORVMS-PRES PRESSURE CUFF CONTROLLER
Manufacturer
MOOR INSTRUMENTS LTD.
Date Cleared
2010-11-18
(84 days)
Product Code
DPW
Regulation Number
870.2100Why 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
K083082Device 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
878.4810Why 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
K060976Device Name
MOORLD12-B1 LASER DOPPLER BURNS IMAGER
Manufacturer
MOOR INSTRUMENTS LTD.
Date Cleared
2007-03-27
(351 days)
Product Code
DPT, GEX
Regulation Number
870.2120Why 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
K063586Device Name
MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
Manufacturer
MOOR INSTRUMENTS LTD.
Date Cleared
2007-01-25
(55 days)
Product Code
DPT, GEX
Regulation Number
870.2120Why 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
K063561Device Name
MOORLDLS LASER DOPPLER LINE SCANNER
Manufacturer
MOOR INSTRUMENTS LTD.
Date Cleared
2007-01-19
(53 days)
Product Code
DPT
Regulation Number
870.2120Why 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
K032841Device 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
870.2120Why 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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