(15 days)
DIGITAL RADIOGRAPHY CXDI-40EC provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The Canon digital radiography CXDI-40EC is used to directly capture and convert conventional projection Xray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.
The provided text describes a 510(k) summary for the Canon CXDI-40EC digital radiography device. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria, specific device performance metrics, or details of a study proving the device meets acceptance criteria in the manner requested (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).
The summary primarily discusses:
- Device Description: The CXDI-40EC is a digital radiography device for capturing and converting X-ray images. Its key difference from a predicate (CXDI-40EG) is the use of CsI (Cesium Iodide) as the fluorescent screen material, leading to higher X-ray absorption, lower dose requirements, and approximately double the DQE (Detective Quantum Efficiency) compared to the GOS (Gadolinium Oxy Sulfide) used in CXDI-40EG. It is similar to CXDI-40C in sensor characteristics but differs in the control PC interface.
- Intended Use: Replaces radiographic film/screen systems in all general-purpose diagnostic procedures, excluding mammography.
- Substantial Equivalence: The submission asserts substantial equivalence based on similar amorphous silicon array specifications, imaging principle, intended use, and design control activities, despite the differences in fluorescent screen material and control PC interface.
Therefore, I cannot provide the requested information from the given text because it is not present in the document. The document is a regulatory submission focused on substantial equivalence to predicate devices, not a detailed performance study with explicit acceptance criteria and corresponding results.
§ 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.