(18 days)
The CPS LSO PET/CT HiRez 64 system is a combined position emission tomography (PET) and X-ray computed tomography (CT) scanner. The LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected position emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and 2) to produce 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 and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)
The CPS LSO PET/CT Hi-Rez 64 system is a combined Positron Emission Tomography and X-Ray Computed Tomography scanner. The system is an addition to the current CPS PET/CT Hi-Rez Family of PET/CT systems and is essentially identical to the commercially available CPS LSO PET / CT Hi-Rez 16 system (K033431) with the exception of a higher resolution CT system -Siemens 64 slice CT (K040665).
The system is designed for whole-body oncology, neurology and cardiology examinations. The PET / CT 64 gantry system consists of a separate PET and CT gantry that retain their independent scanning mechanisms, including mechanical and electrical components. In addition, it provides registration and fusion of high-resolution metabolic and anatomic information from the two major components of the system, the Accel Hi-Rez LSO PET scanner and the Siemens Somatom Sensation 64 CT.
The difference between the current Sjemens Sensation 16 used in the commercially available CPS PET/CT systems is the number of slices acquired per rotation. Current PET/CT's are capable of acquiring 16 slices per rotation while the Sensation 64 is capable of acquiring 64 slices per rotation, thus increasing the resolution of the acquired CT scan.
The provided text is a 510(k) summary for the LSO PET/CT HiRez 64 system, which describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states:
- "The system is an addition to the current CPS PET/CT Hi-Rez Family of PET/CT systems and is essentially identical to the commercially available CPS LSO PET / CT Hi-Rez 16 system (K033431) with the exception of a higher resolution CT system -Siemens 64 slice CT (K040665)."
- "The difference between the current Siemens Sensation 16 used in the commercially available CPS PET/CT systems is the number of slices acquired per rotation. Current PET/CT's are capable of acquiring 16 slices per rotation while the Sensation 64 is capable of acquiring 64 slices per rotation, thus increasing the resolution of the acquired CT scan."
This indicates that the device's approval is based on its substantial equivalence to previously cleared devices, primarily due to the upgrade of the CT component to a higher-resolution 64-slice system. It does not detail new performance studies against specific acceptance criteria for the combined system.
Therefore, I cannot provide the requested table and information as the input document does not contain this data.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.