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510(k) Data Aggregation

    K Number
    K141208
    Device Name
    DYNAMIC NEUROSCREENING DEVICE
    Manufacturer
    PROSENEX
    Date Cleared
    2014-07-23

    (75 days)

    Product Code
    LQW, LLN
    Regulation Number
    882.1200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dyaamic Newssreaing Device (DND) is intended to provide objective medical screening for peripheral newopathy by determining the patient's ability to discriminate temperature differences as well as determining vibration sensitivity.
    Device Description
    The Dynamic Neuroscreening Device (DND) is intended to screen patients and allow the practitioner to observe uny changes of sensation over a period of time. The device will be available with a cradle which provides a docking location for the handle. The DND device provides medical practitioners with an objective method for screening patient's feet for neuropathy. The device uses two methods for long term screening with the objective of determining loss of sensation in the patient's foot: vibration sensitivity and temperature discrimination screening. The primary patient population is for those that arc at risk or have been diagnosed with diabetes. The DND is designed to be ergonomically comfortable in the practitioner's hand and simple to use. In addition safety features are installed to provent the device from becoming excessively hot or cold to ensure untient safety. No electrical pathways are going to the patient and the power supply is UL upproved to the medical device standard.
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    K Number
    K072882
    Device Name
    PAIN VISION, MODEL PS-2100
    Manufacturer
    OSACHI CO., LTD.
    Date Cleared
    2009-01-08

    (457 days)

    Product Code
    LLN
    Regulation Number
    882.1200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-2100's examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.
    Device Description
    The PS-2100 is a type of Sensory Nerve Threshold Measurement System Device. The electrical stimulus is applied in gradually increasing amounts to the electrode attached to the patient. Disposable gel electrodes are attached to the patient connecting the electrode. The current value at which the patient initially senses the stimulation is referred to as the Current Perception Threshold (C.P.T.) value. Measurement may be conducted in one of two modes - Standalone mode by which the device itself is used for measurements, and System mode whereby the device is connected to a personal computer for administration of data. The patient is provided a hand switch to cease measurement at any time during the test.
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    K Number
    K042257
    Device Name
    DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
    Manufacturer
    GENERAL ELECTRIC CO.
    Date Cleared
    2004-09-08

    (19 days)

    Product Code
    KPS
    Regulation Number
    892.1200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GE Discovery ST System with the alternate detector option is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST with alternate detector option is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST with alternate detector option can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
    Device Description
    The Discovery ST PET/CT Imaging System an with alternate detector option integrates a GE Positron Emission Tomography system and a GE LightSpeed CT System. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy.
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    K Number
    K030829
    Device Name
    VPT METER
    Manufacturer
    XILAS MEDICAL, INC.
    Date Cleared
    2003-12-05

    (266 days)

    Product Code
    LLN
    Regulation Number
    882.1200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.
    Device Description
    The Xilas Medical VPT Meter is designed to identify patients with sensory neuropathy. These patients have lost sensation and the "gift of pain" from their extremities or elsewhere. The instrument provides a quantitative measurement of vibration perception threshold (VPT). The digital device allows the clinician to quantify the loss of sensation, initially to establish a baseline loss of sensation and subsequently monitor the progression of established pathology.
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    K Number
    K964622
    Device Name
    MEDI-DX 7000
    Manufacturer
    NEURO-DIAGNOSTIC ASSOC.
    Date Cleared
    1997-12-01

    (378 days)

    Product Code
    LLN
    Regulation Number
    882.1200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi-Dx 7000 is a diagnostic device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The Medi-Dx 7000 diagnostic examination may be conducted as part of a routine neurological examination or as a screening procedure for the detection of peripheral neuropathy which may be caused by various pathological conditions or exposures to toxic substances.
    Device Description
    The Medi-Dx 7000 is a Current Perception Threshold (CPT) device for the examination of peripheral neuropathies. It generates a sinusoidal electrical currents in the 5 Hz, 250 Hz and 2000 Hz frequencies from 0 mA to 9.99 mA. The Medi-Dx 7000 weighs approximately 15 lbs. and is housed within a 12" x 6" x 11" heavy duty plastic case with metal face and rear panels. The rear panel has an access door for installation and replacement of (8) standard (6) Volt Alkaline Batteries. The Face panel has an 'ON/OFF' switch, a 'Battery Test' switch (also functioning as an automatic calibration switch), and three (3) switches, one for each of the frequencies; 5 Hz, 250 Hz and 2000 Hz respectively. The intensity control is immediately below an LCD which reads mA output. Two ports are available on the from panel for connection with electrodes (which are not provided with the unit and are ordered by the user from suppliers mentioned in the owners manual).
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    K Number
    K964815
    Device Name
    AP-4000, AIR PULSE SENSORY STIMULATOR
    Manufacturer
    PENTAX PRECISION INSTRUMENT CORP.
    Date Cleared
    1997-09-04

    (279 days)

    Product Code
    LLN
    Regulation Number
    882.1200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AP-4000, Air Pulse Sensory Stimulator, is intended to elicit Laryngeal Closure Reflex (Swallow) and to measure the sensory discrimination threshold at which the reflex occurs in the area of the Upper Airway innervated by the Superior Laryngeal Nerve. The structures being stimulated in the area of the Upper Airway innervated by the Superior Laryngeal Nerve are: the Left and Right Anterior Wall of the Pyriform Sinus and the Left and Right Aryepiglottic Folds. The device is intended to be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso -Pharyngo- Laryngo Scope, introduced per nasally in Adult and Pediatric patient populations with suspected Dysphagia.
    Device Description
    The AP-4000, Air Pulse Sensory Stimulator, is an endoscopic accessory that must be used with the Pentax FNL-10AP or FNL-10RAP, Fiber Naso-Pharyngo-(Laryngo) Scopes. The AP-4000 is a software controlled device. The device contains an Air Pump and the mechanics to control the pressure of a 5 0 millisecond (ms) air pulse, delivered through the FNL-10AP working channel. The device is connected to the endoscope working channel with an Air Supply Tube (two pieces are included with the device as standard set components). The device front panel has controls and displays to allow a desired pressure for the 50 ms air pulse to be selected (in the range 2 mm Hg to 10 mm Hg), the air pulse to be initiated, and the actual pressure of the delivered air pulse to be displayed. There are connections for the Air Supply Tube (to the endoscope working channel), a pneumatic footswitch (alternate control to initiate air pulse, one piece is included as a standard set component), and an RS-232 connection so that unit displays may be available to other system peripheral devices (Addon Camera).
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    K Number
    K970180
    Device Name
    VSA 3000 VIBRATORYN SENSORY ANALYZER
    Manufacturer
    EARE CONSULTING SERVICE
    Date Cleared
    1997-04-25

    (98 days)

    Product Code
    LLN
    Regulation Number
    882.1200
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various neuropathies may exist.
    Device Description
    The VSA 3000 - Vibratory Sensory Analyzer is a computerized device for the quantitative assessment of large nerve fiber dysfunction, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration.
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