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Found 25 results
510(k) Data Aggregation
K Number
K233076Device Name
Laser Speckle Imaging System (RFLSI CZW)
Manufacturer
RWD Life Science Co., Ltd.
Date Cleared
2024-05-28
(245 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Product Code :
DPT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use.
Device Description
The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use. It is a measurement tool based on the laser speckle contrast analysis technology and provides real-time blood perfusion information of tissue and organs in a visual and quantitative way. The device is non-patient contacting and does not require the use of contrast agents.
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K Number
K163339Device Name
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
Manufacturer
SPECTRALMD, INC.
Date Cleared
2017-08-17
(262 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Product Code :
DPT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SpectralMD™ DeepView™ Wound Imaging System 2.0 is an optical imaging device intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, neurosurgery and anesthetics. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery), chronic wounds, decubitus ulcers and diabetic ulcers.
Device Description
The DeepView System 2.0 is a prescription device that utilizes the principles of non-contact photoplethysmography (PPG) to capture images of tissue blood perfusion. This is accomplished by measuring the optical properties of tissues and blood as they vary in response to changing hemodynamic conditions. The device's software combines real-time digital analysis based on the interaction of light with vascular tissues below the skin's surface to produce 2-D color images on a touch-screen display depicting relative blood perfusion. The DeepView System consists of a Camera Head with LED optics, an Articulating Arm for Camera Head positioning, a Touch-Screen Display for image viewing, and for accessing and interacting with the Graphical User Interface (GUI). All components are integrated on a Mobile Cart that houses the hardware/software, uninterruptable power supply (UPS), and allows for transport between use environments. The DeepView System 2.0 is AC powered with a backup UPS, and is for use in healthcare/hospital facilities.
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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?
Product Code :
DPT
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
K142932Device Name
Deltex Medical KDP72 Doppler Probe
Manufacturer
DELTEX MEDICAL LIMITED
Date Cleared
2015-01-22
(105 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Product Code :
DPT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The probe is for use with the Deltex Medical CardioQ-EDM and CardioQ-EDM+ for Monitoring of cardiac output and fluid status. The probe is only approved for oral placement into the esophagus of a single anesthetized patient 15 years of age or younger, 50cm (20") to 170cm (67") in height.
Device Description
The Deltex Medical Ltd KDP72 Pediatric Doppler Probe is an oral extravascular blood flow probe designed to work with the CardioQ-EDM and CardioQ-EDM+ Systems (K111542 and K132139 respectively). It consists of a shaft, which is a spring reinforced silicone tube, with an electrical connector on the machine end and an ultrasonic transmitting and receiving tip on the patient end. The tip is fully covered and sealed to the shaft with a silicone rubber boot and by wires running through the shaft to the connector. Visual product identification is provided at the machine end and the device is provided single packed sterile for single patient use.
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K Number
K132730Device Name
BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE
Manufacturer
MEDTRONIC INC.
Date Cleared
2014-05-30
(269 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Product Code :
DPT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K133903Device Name
BIO-PROBE TRANSDUCER (ADULT)
Manufacturer
MEDTRONIC INC.
Date Cleared
2014-04-10
(111 days)
Product Code
DPT, CLA
Regulation Number
870.2120Why did this record match?
Product Code :
DPT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.
Device Description
The Bio-Probe 10 Blood Flow Monitoring System consists of a flow transducer and a sterile, single-use insert. The flow transducer consists of a flow-meter, cable and connector. The TX50 (adult) and TX50P (pediatric) transducer models are reusable. The Bio-Probe blood flow monitoring system can be used to measure the patient blood flow during the extracorporeal procedure.
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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?
Product Code :
DPT
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
K124049Device Name
DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM
Manufacturer
Spectral MD, Inc
Date Cleared
2013-04-18
(108 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Product Code :
DPT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spectral MD DeepView system is intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, physiology, neurosurgery and anesthetics.
Device Description
Deep View system-based technology combines real-time digital analysis of optical signatures, thereby sensitizing an imager to photon-tissue interactions deep below the skin's surface. These image signatures are unique to the body and relate directly to a person's dynamic nature - both in terms of the quantity and quality of important physiological properties. This technology is non-invasive and uses no harmful radiation such as X-rays and allows clinical investigators to look deeper into the body, delivering images of blood flow under the skin's surface without ever touching the patient.
The DeepView system is composed of a mobile cart with uninterruptible power supply, a laptop computer with remote multimedia keyboard, an LCD screen mounted on a bracket that allows for side-to-side panning, a mechanical arm, a CMOS camera with DSP electronics, and disposable LED cartridges with an associated LED driver control board.
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K Number
K123216Device Name
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
Manufacturer
AIMAGO SA
Date Cleared
2013-02-07
(115 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Product Code :
DPT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aïmago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery) and hand surgery.
EasyLDI Studio is intended to be used as offline viewer application for snapshots, videos and references recorded with the Aïmago EasyLDI Microcirculation Camera.
Device Description
The Aïmago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It is a medical diagnostic imaging device which serves to visualize the perfusion of cutaneous microcirculation in the form of arbitrary units in real-time. The EasyLDI uses the established laser Doppler technique performing a 2-dimensional area scan to build up a color coded image of the blood flow in the tissue. In the form of arbitrary units, this image allows the surgeon to quantify movement of blood cells beneath the skin surface.
The software changes implemented in the Aïmago EasyLDI microcirculation camera V2.X allow the user different modes of displaying the information on the built-in screen, thus facilitating the assessment of the microcirculation patterns for the specified applications.
EasyLD! Studio is a standalone software which runs on Windows systems. It is an optional accessory to the Aïmago EasyLDI microcirculation camera. It can be used to view LDI items (i.e. LDI snapshots, videos or references previously recorded with the Aïmago EasyLDI) on a commercially available desktop computer.
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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?
Product Code :
DPT
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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