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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
No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution
- B201CGSCENERGY1 ()
- B201CGSCENERGY0 ()
- Ultrasound imaging system application software
- Stereotactic system application software
AirView
RESMED CORP.
22240
In Commercial Distribution
- 00840193400276 ()
22240
- Ventilator application software
- Medical equipment clinical data interfacing software
EMYO®100S is a Single Channel EMG System for dysphagia rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO® 100S
In Commercial Distribution
- 00852423006486 ()
EM100S
- Psychophysiological biofeedback system
EMYO® 200S is a dual channel EMG System for dysphagia rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO® 200S
In Commercial Distribution
- 00852423006479 ()
EM200S
- Psychophysiological biofeedback system
Morpheus® Transperineal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
RTTU
In Commercial Distribution
- 00852423006462 ()
RTTU
- Extracorporeal ultrasound imaging transducer, hand-held
EMYO®100 is a Single Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO®100
In Commercial Distribution
- 00852423006455 ()
EM100-N
- Psychophysiological biofeedback system
EMYO®200 is a Dual Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO®200
In Commercial Distribution
- 00852423006448 ()
EM200
- Psychophysiological biofeedback system
9250-ST Telesis® ST Software for Speech Therapy MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250-ST
In Commercial Distribution
- 00852423006431 ()
9250-ST
- Biofeedback system application software