(69 days)
SDX-4343GV digital flat panel X-Ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy targeting both adult and children. 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. Not to be used for mammography.
SDX-4343GV digital X-ray flat panel detectors can generate radiographic images of any part of the body. Each of them consists of a scintillator directly coupled to an a-SI TFT sensor. It makes high-resolution, high-sensitive digital images. SDX-4343GV 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 the user's designated console software which is not included in SDX-4343GV, digital flat panel X-ray detector.
The provided document is a 510(k) summary for the SDX-4343GV Digital Flat Panel X-Ray Detector. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria related to device performance (e.g., sensitivity, specificity, or accuracy metrics) or a study that specifically proves the device meets such criteria.
The document primarily focuses on regulatory compliance, outlining:
- Company and device information.
- Comparison with a predicate device (LLX240AB01).
- Statement of compliance with electrical, mechanical, environmental, and EMC safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 61000-3-2, EN/IEC 61000-3-3).
- Conclusions regarding safety, effectiveness, and substantial equivalence.
Therefore, I cannot populate the requested table and answer the study-specific questions as the necessary information is not present in the provided text. The document confirms that "All test results were satisfactory" for safety and performance testing according to the listed standards, but it does not detail specific performance metrics, acceptance criteria, or the methodology of a clinical or performance study that would demonstrate such.
§ 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.