(193 days)
The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The Orion fluoroscopic imaging system allows the use of digital imaging to conventional X-ray system used in the general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging arcas. The system works by installing a CCD camera on the output of the image intensifier and digitizing the video output of the image intensifier. The digital image can then be displayed on the monitor, it can be stored to disk, or sent to an external device such as a laser imager or a DICOM network. The image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
The provided document is a 510(k) summary for the InfiMed Orion Fluoroscopic Imaging System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance metrics, or a study detailing how the device meets such criteria.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or training set details as this information is not present in the provided text.
The document primarily focuses on:
- Device Description: A digital radiography system that replaces conventional film techniques in various fluoroscopic applications.
- Intended Use: High-resolution digital imaging for general fluoroscopy, interventional fluoroscopy, angiography, and cardiac imaging, allowing image viewing, enhancement, storage, and networking.
- Substantial Equivalence: Claims substantial equivalence to the InfiMed GoldOne and FC2000 Fluoroscopic Systems based on features and increased power.
To fulfill your request, a different type of document, such as a validation study report or a more detailed section of the 510(k) submission, would be required.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.