(31 days)
The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.
ImagenPRO™ is a software application installed on desktop computers which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angles. 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.
The provided text does not contain any information about acceptance criteria, device performance metrics, or any study design details.
The document is a 510(k) summary for the ImagenPRO™ system, which is a software application for viewing, reconstructing, and reorienting myocardial perfusion PET images. The focus of the provided text is on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
The key points from the provided text are:
- Device Description: ImagenPRO™ is a software application for inspecting, reconstructing, and reorienting myocardial perfusion PET images.
- Indications for Use: To visualize raw PET/CT data, reconstruct myocardial perfusion PET/CT images, and reorient PET/CT reconstructed tomograms.
- Predicate Devices: Siemens/CTI Accel (K002584) and GE Discovery LS (K023988).
- Substantial Equivalence: The document states that "Testing and comparison of technological characteristics and intended uses found that all resting and companison of won™ system are equivalent to the predicates." This is the primary "proof" presented, but it's a comparison of characteristics and intended uses, not a performance study against specific acceptance criteria.
- FDA Clearance: The letter confirms the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this information is not present in the provided text.
§ 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.