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No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130211007M
In Commercial Distribution
- 06947145578053 ()
130211007M
- Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130202022M
In Commercial Distribution
- 06947145578046 ()
130202022M
- Total human chorionic gonadotropin IVD, control
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130602022M
In Commercial Distribution
- 06947145578039 ()
130602022M
- Total human chorionic gonadotropin IVD, control
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130203016M
In Commercial Distribution
- 06947145577988 ()
130203016M
- Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130603016M
In Commercial Distribution
- 06947145577971 ()
130603016M
- Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130603013M
In Commercial Distribution
- 06947145500023 ()
130603013M
- Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
No Description
Shenzhen New Industries Biomedical Engineering Co., Ltd.
130203013M
In Commercial Distribution
- 06947145500016 ()
130203013M
- Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
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
KIT, AVEA UPGRADE GDE & SOFTWARE
VYAIRE MEDICAL, INC.
12284-PMN
Not in Commercial Distribution
- 10190752159075 ()
12284-PMN
- Patient monitoring system module, pulse oximetry
- Ventilator application software