(64 days)
The Flat Panel Digital X-ray Detector 10HQ701G-B is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
This model is an x-ray imaging device, a system that can acquire and process X-ray images as digital images. It utilizes amorphous silicon and a high-performance scintillator to ensure sharp high-definition image quality with the resolution of 3.6 lp/mm and the pixel pitches of 140 um. This device is a flat panel based X-ray image acquisition device. This device must be used in conjunction with an operating PC and an X-ray generator. This device can be used for digitizing and transferring X-ray images for radiological diagnosis. The data transmission between the Detector and PC can be enabled with a wired (cable) or wireless connection.
The provided document does not contain specified acceptance criteria or detailed results of a clinical study demonstrating how the device meets acceptance criteria. The document states that "Clinical data has been provided according to FDA guidance document 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices.' The data was not necessary to establish substantial equivalence based on the modifications to the device but provided further evidence in addition to the laboratory performance data to show that the device works as intended." This indicates clinical data was submitted, but the summary does not include the details of that study, such as specific acceptance criteria, performance metrics, sample size, ground truth establishment, or expert qualifications.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K182348) based on technological characteristics and non-clinical performance tests (electrical safety, EMC, software validation, biocompatibility, and imaging performance according to IEC 62220-1).
Therefore, I cannot provide the requested information from the given text.
§ 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.