(178 days)
SDX-4336CP Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy for adults and pediatric care. It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals who are licensed by the law of the State in which he or she practices to use the device. Not to be used for mammography.
The SDX-4336CP is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4336CP is designed specifically to be integrated with an operating PC and a X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW.
SDX-4336CP is an X-Ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and a X-Ray generator. It can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic
The provided text is a 510(k) summary for a Digital Flat Panel X-Ray Detector (SDX-4336CP). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria, device performance results, details of a study (test set size, data provenance, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for the training set).
The document states that "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory." but does not elaborate on the specific acceptance criteria or the reported performance data from these tests. These tests are general safety and EMC standards, not specific clinical performance studies that would typically assess diagnostic accuracy.
Therefore, I cannot populate the table and answer the study-related questions based on the provided text. The submission focuses on device description, intended use, and substantial equivalence, not a detailed clinical performance study with the requested metrics.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.