(121 days)
The PathVisionXL is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
The PathVisionXL is specially designed for high detail radiographic imaging of surgically excised medical specimens. It is a fully shielded Cabinet X- ray System that has been designed to comply with 21 CFR 1020.40. The larger (XL) cabinet allows up to 10.0 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 15 microns. With optimized cabinet geometry and the superior contrast available from the low kV capability, the PathVisionXL provides enhanced image performance. It is designed to acquire a large high resolution digital images up to 43 x 43 cm in size, through the use an integrated digital X-Ray detector and Faxitron Vision software. The Faxitron Software supports the DICOM Store, Print and Modality Worklist services.
The provided text does not contain information about acceptance criteria for a specific device performance, nor does it detail a study proving such criteria are met. The document is an FDA 510(k) premarket notification for the PathVisionXL, focusing on its substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table and study details. The document primarily addresses the safety, technological characteristics, and regulatory compliance of the PathVisionXL as a cabinet x-ray system for specimen radiography.
§ 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.