(83 days)
LLX240AB0! 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.
LLX240AB01 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. LLX240AB01 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. LLX240AB01 is a 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 be utilized for digitalizing x-ray images by converting X-ray photons into visible light and then to electronic image data that a computer can read and display for diagnostic purposes.
I am sorry, but I am unable to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is a 510(k) submission summary for a Digital Flat Panel X-Ray Detector, and it focuses on general information about the device, its classification, and its substantial equivalence to a predicate device.
The provided text does not contain any information regarding:
- Specific acceptance criteria for device performance (e.g., sensitivity, specificity, image quality metrics).
- Details of a study proving the device meets acceptance criteria.
- Sample sizes for test sets, data provenance, or ground truth establishment.
- Information on expert readers, adjudication methods, or MRMC studies.
- Details on standalone algorithm performance.
- Training set information.
The document primarily 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." This is a general statement about regulatory compliance and safety testing, not specific clinical performance criteria or a comparative study against such criteria.
§ 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.