The VOLCANO system is used for the qualitative and quantitative evaluation of the vascular morphology in the coronary arteries and vessels of the peripheral vasculature. They are also indicated as a complement to conventional angiographic procedures to provide an image of the vessel lumen and option wall structures. CHROMAFLO is indicated for qualitative information about the blood flow of the coronary and peripheral vasculature; this information can complement other methods used to estimate perfusion and blood flow. The VH IVUS system is intended to be used in conjunction with imaging catheters during ultrasound imaging of the peripheral and coronary vasculature. The VOLCANO VH IVUS system aims to visualize, in a semi-automatic manner, characteristics of the limits and perform spectral analysis of RF ultrasound signals, which the user may wish to follow more closely during routine diagnostic ultrasound imaging exams. The pressure function is designed to be used in all blood vessels, including the coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and / or intervention procedures. The VOLCANO S5I system provides diagnostic information when used in conjunction with catheters deformation of images during VOLCANO formation of ultrasonic images of the peripheral and coronary vasculature. It is intended to be used as an adjunct to conventional angiographic procedures or interventional therapies such as balloon angioplasty.
The recalled GEMINI TF 16 system units are identified as follows: Model Number: 882470 and Model #882473, Serial Numbers: 7228, 7230, 7233, 7235, 7239, 7240, 7242, 7244, and 7237.
Nationwide Distribution including the states of CO, LA, MD, MI, MN, PA, TX, VA, VT, and WI.
Description du dispositif
Philips GEMINI TF 16 Diagnostic CT X-ray/PET Imaging System, 510(k) #K052640. System units equipped with software version: 3.5.2 are subject to recall/field correction. || The GEMINI TF I6, and TF 64 are diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.
Description du dispositif
Philips GEMINI TF16 Diagnostic Imaging Systems, Model Number: 882470, 510(k) #K052640, Serial Numbers: 7501, 7503, 7507, 7508, 7011, 7047, and 7174. The recalled GEMINI TF16 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. || The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.
Worldwide distribution: USA including states of: FL, MA, NE, NC, OH, TX, WA and WV; and countries of: France, Germany, Italy, Kuwait, The Netherlands, Spain and Turkey.
Description du dispositif
Philips GEMINI TF64 Diagnostic Imaging Systems, Model Number: 882471, 510(k) #K052640, Serial Numbers: 7502, 7504, 7506, 7514, 7083 and 7164. The recalled GEMINI TF64 system units equipped with software versions: 3.5.1.1 and 3.5.2.1 are subject to recall/software correction. || The GEMINI TFI6, TF64 and TF Big Bore (BB) are all diagnostic imaging systems for fixed or mobile installations that combine Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CT AC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.