Neuron-Spectrum-AM With Neuron-Spectrum.NET Software
Neurosoft Ltd.
Neurosoft Ltd.
PMN#
Neuro-IOM System With Neuro-IOM.NET Software
Neurosoft Ltd
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE
NEUROSOFT LTD
NEUROSOFT'S SOURCE
NEUROSOFT, INC.
CURRY MULTIMODAL NEUROIMAGING SOFTWARE
NEUROSOFT, INC.
NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8
NEUROSOFT, INC.
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
NEUROSOFT, INC.
GUDID#
CloudTMS Edge - The CloudTMS Edge system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
2026-01-23
CloudTMS Edge - No description
2026-01-23
Rivus - The uroflowmeter is intended to quantify the flow characteristics of the lower urinary tract. The uroflowmetry is used for patients with urinary incontinence, abnormal urinary retention.
2024-12-20
Rivus - The uroflowmeter is intended to quantify the flow characteristics of the lower urinary tract. The uroflowmetry is used for patients with urinary incontinence, abnormal urinary retention.
2023-02-02
CloudTMS Edge for OCD - No description
2024-01-12
CoudTMS Edge for OCD - No description
2024-01-12
CloudTMS Edge for OCD - The CloudTMS Edge stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)
2024-01-12
CloudTMS for OCD - No description.
2023-12-14
CloudTMS for OCD - No description.
2023-12-14
CloudTMS for OCD - The Cloud TMS stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
2023-12-14
Neuro-Audio - The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation, documentation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA).The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories.The patient group includes all ages and genders.
2016-09-22
Steadys-Step - System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) data obtained with inertial sensors.
2023-08-14
CloudEKG - The CloudEKG device is a 12 standard leads battery operated unit intended for recording and transmitting standard electrocardiogram signals for cardiac monitoring and diagnosis by healthcare professionals.Recorded signals are processed by the device and transmitted to a PC or hand-held monitoring device wirelessly using Bluetooth technology.The transmitted signals are displayed on the monitoring device to allow for their review, analysis, saving and printing by healthcare professionals.CloudEKG can be 'used in adults and infants weighing less than 22 lbs (10 Kg) but is not appropriate for use to monitor critical patients or perform intracardiac recordings.All measurements obtained with the CloudEKG device should take into account the patient's clinical symptoms and findings to be considered valid and no treatment by drugs or other therapies should be initiated based solely on the measurements obtained with the device.
2016-09-21
CloudTMS - The CloudTMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.The Cloud TMS stimulator is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
2017-12-21
aTymp - The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders with the help of acoustic impedance tests, including tympanometry, Eustachian tube function (for intact and perforated tympanic membrane), acoustic reflex and acoustic reflex decay.The target population for aTymp system includes all ages.During the Eustachian tube function tests patient should be able to understand and perform instructions to do maneuvers.
2023-02-02
Neuron-Spectrum-AM - Indications for UseThe Neuron-Spectrum-AM system with Neuron-Spectrum.NET software is intended for use as a digital neurophysiological system for recording, processing, and displaying biopotential signals such as Electroencephalography (EEG) and Polysomnography (PSG) derived from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The device is portable and can register up to 21 EEG channels, 4 polygraphic channels, 1 breath channel, and 1 direct current channel. The device does not provide alarms, does not provide automated event marking and does not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in patient care institutions, diagnostics centers, neurosurgical hospitals, experimental laboratories, and sleep laboratories. The device can also be used as a home use device under supervision of qualified personnel. The patient group includes all ages and sexes.
2022-12-19
Neuron-Spectrum - The digital systems Neuron-Spectrum- 4/P are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 21EEG channels, up to 4 polygraphic channels ,1 breath channel and 2 direct current channels.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes
2016-09-22
Neuron-Spectrum - The digital systems Neuron-Spectrum-4 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 21 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.
2016-09-22
Neuron-Spectrum - The digital systems Neuron-Spectrum-3 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 19 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.
2016-09-22
Neuron-Spectrum - The digital systems Neuron-Spectrum-2 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 16 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.
2016-09-22
Neuron-Spectrum - The digital systems Neuron-Spectrum-1 are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 8 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.
2016-09-22
Focus - 2-channel neurodiagnostic testing system designed to enable reliable recording, display and documentation of electrophysiological information from thehuman nervous and muscular systems in a clinical environment. The system enables the healthcare provider to perform evoked potentials, nerve conductions and needle EMG studies as an aid in the evaluation of patients with central and peripheral nervous system symptoms.
2016-09-22
Neuron-Spectrum - The digital systems CloudEEG are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes.The devices are portable and can register up to 19 EEG channels, 1 polygraphic channel and 1 breath channel.The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.
2021-07-22
Neurosoft - The Neurosoft TMS system is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.
2017-06-05
MEGA-TMS - The device is intended for magnetic stimulation of peripheral nerves. The obtained responses of stimulated structures can be recorded with EMG system for further diagnostic evaluation.
2021-08-22
Neuro-IOM - Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status.The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations:I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (au-ditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed.The system is not intended to measure the vital signs. It records the data to be inter-preted by the neuromonitoring specialist.
2021-06-10