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Cassette Printer with AutoLoader
SAKURA FINETEK U.S.A., INC.
9020
In Commercial Distribution
- 00615233082374 ()
9020
- Cell morphology analyser IVD, automated/semi-automated
- Computed radiography digital imaging scanner
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest.
Infervision Medical Technology Co., Ltd
5.0.2.5
In Commercial Distribution
- 00850003095042 ()
- X-ray image interpretive software
- Diagnostic x-ray digital imaging system workstation
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Infervision US Inc
1.1.0.0
In Commercial Distribution
- 00850003095011 ()
- Diagnostic x-ray digital imaging system workstation
- X-ray image interpretive software
Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Infervision US Inc
2.1.2.1
In Commercial Distribution
- 00850003095004 ()
- X-ray image interpretive software
- Diagnostic x-ray digital imaging system workstation
ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.
The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation.
In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
3.0
In Commercial Distribution
- 00862611000349 ()
- SPECT system application software
- Radiology DICOM image processing application software
The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
2.0
In Commercial Distribution
- 00862611000301 ()
- SPECT system application software
- Radiology DICOM image processing application software
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb.
The MyoPro 2x Assembly Kit consists of a combination of the following components, some or all of which are not yet assembled: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station.
The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate
and complete desired motions.
Myomo, Inc.
Motion G Right - 30382 rev1
In Commercial Distribution
- 00855846007252 ()
30382
- Psychophysiological biofeedback system
- Elbow orthosis
- Hand orthosis
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb.
The MyoPro 2x Assembly Kit consists of a combination of the following components, some or all of which are not yet assembled: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station.
The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate
and complete desired motions.
Myomo, Inc.
Motion G Left - 30381 rev1
In Commercial Distribution
- 00855846007245 ()
30381
- Psychophysiological biofeedback system
- Elbow orthosis
- Hand orthosis
The Mobile Arm Rehabilitation Kit version 2 (MARK2) is a kit containing two (left and right) MyoPro upper extremity limb orthoses. A MyoPro upper extremity limb orthosis is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb.
The MARK2 product consists of a combination of the following components: shoulder harnesses, adjustable limb orthoses (braces), powered elbow orthoses with surface electromyography (EMG) sensors, static or manually set multi-articulating wrists (MAW), static hand orthoses or powered hand orthoses with EMG sensors, an interchangeable battery with a separate recharging station, an MTS chafe with loop for anti-rotation strap, a laptop, and a product carrying case/bag.
The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. A MyoPro device filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro to assist the User to initiate and complete desired motions.
Myomo, Inc.
MARK2 29860
In Commercial Distribution
- 00855846007238 ()
MARK2 29860
- Psychophysiological biofeedback system
- Elbow orthosis
- Hand orthosis
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb.
The MyoPro 2x consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station.
The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate
and complete desired motions.
Myomo, Inc.
Motion G Right - 29858 rev1
In Commercial Distribution
- 00855846007221 ()
29858
- Psychophysiological biofeedback system
- Elbow orthosis
- Hand orthosis