Symbia T2 serial number 2001; Symbia Intevo Excel serial numbers 2112 and 2140; Symbia Intevo 16 serial numbers 2100 and 2116; Symbia Evo serial numbers 1049, 1054, 1071, 1075, 1104, and 1128; and Symbia Evo Excel serial numbers 1109, 1111, 1131, 1134, and 1158.
Distribution was made to medical facilities located in CA, FL, GA, LA, NY, PA, and TN. There was government distribution but no foreign/military distribution.
Description du dispositif
Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
Worldwide Distribution: US (Nationwide) including states of: District of Columbia and Puerto Rico and countries of: Algeria, Argentina, Austria, Australia, Bangladesh, Bahrain, Belarus, Belgium, Brazil, Cameroon, Canada, Chile, China, Colombia, Congo-The Democratic Republic of the, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Great Britain, India, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Lebanon, Mauritius, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Serbia (Republic of Serbia), South Africa, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, Uzbekistan, Viet nam, and Yemen.
Description du dispositif
e.cam and Symbia E gamma camera systems with patient beds || To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.
Biograph mCT Systems: || (a) Biograph mCT S(64)-3R, Material Number 10248669 || Product Usage: || The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. || (b) Biograph mCT S(40)-4R, Material Number 10248671 || (c) Biograph mCT S(64)-4R, Material Number 10248672 || (d) Biograph mCT X-4R, Material Number 10248670 || (e) Biograph mCT X-3R, Material Number 10248673 || (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 || (g) Biograph mCT Flow Edge-4R, Material Number 10528955 || (h) Biograph mCT S(40)-3R, Material Number 10248668 || (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 || (j) Biograph mCT Flow 40-4R, Material Number 10529159 || (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745
Domestic distribution to . International distribution to Finland, France, France, Iran, Ireland, Italy, Japan, Japan, Netherlands.
Description du dispositif
Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.