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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
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
AirView
RESMED CORP.
22240
In Commercial Distribution
- 00840193400276 ()
22240
- Ventilator application software
- Medical equipment clinical data interfacing software
No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution
- B201CGSCENERGY1 ()
- B201CGSCENERGY0 ()
- Ultrasound imaging system application software
- Stereotactic system application software
No change in DI justified in the CO. No form fit function, model or version changes triggering a new DI
Ulthera, Inc.
CM1 Rev C, D, E
In Commercial Distribution
- 00840763100384 ()
- Mechanical skin contouring system motor
Neonatal Single-Patient Size #4, Circ: 7.1 - 13.1 cm, incorporates the new connector configuration, replaces the M1872A, 40 cuffs per box.
Philips Medical Systems Hsg
NEONATAL SINGLE-PATIENT CUFF SIZE #4
Not in Commercial Distribution
- 20884838008551 ()
- 00884838008557 ()
- Circumference: 13.1 Centimeter
M1872B
- Blood pressure cuff, reusable
Neonatal Single-Patient Size #3, Circ: 5.8 - 10.9 cm, incorporates the new connector configuration, replaces the M1870A, 40 cuffs per box.
Philips Medical Systems Hsg
NEONATAL SINGLE-PATIENT CUFF SIZE #3
Not in Commercial Distribution
- 20884838008537 ()
- 00884838008533 ()
- Circumference: 10.9 Centimeter
M1870B
- Blood pressure cuff, reusable
Neonatal Single-Patient Size #2, Circ: 4.3 - 8.0 cm, incorporates the new connector configuration, replaces the M1868A, 40 cuffs per box.
Philips Medical Systems Hsg
NEONATAL SINGLE-PATIENT CUFF SIZE #2
Not in Commercial Distribution
- 20884838008513 ()
- 00884838008519 ()
- Circumference: 8 Centimeter
M1868B
- Blood pressure cuff, reusable
TigerView software version 8.4.1
TELEVERE SYSTEMS, LLC
8.4.1
In Commercial Distribution
- 00851800007108 ()
TigerView 8.4.1
- Basic diagnostic x-ray system application software
- Camera application software
- Multidisciplinary medical image management software
- General-purpose dental x-ray system application software
- Radiological PACS software