(81 days)
The UDI 2W system is a direct digital radiographic upgrade unit used to directly capture and convert conventinal projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, it can be printed and/or stored electronically. The Meridian UDI 2W unit provides digital radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The UDI 2W system can be used with a fixed, portable, or wireless 17"X17" or 14"x17" sensor plate. The UDI 2W can not be used for Mammography applications.
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I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Universal Digital Interface 2W (UDI2W) and primarily discusses its regulatory classification, indications for use, and compliance requirements. It does not include details on specific performance metrics, study designs, sample sizes, or expert qualifications.
§ 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.