1/1/2023 0 Comments Gendex vixwin platinumHigh-quality digital images can be shared over a network, making this PSP particularly economical for large practices. The system scans and delivers images for intraoral (0, 1, 2, 3) sizes in seconds, successfully imaging patients of all sizes and all types of anatomies. A touchless end-to-end workflow keeps plates protected, decontaminated, and performing dependably time-aftertime. Replace the cost and inconvenience of the film processor with reusable, long-lasting PSP imaging plates. With the GXPS-500, you’ll efficiently eliminate the cost, time, and messiness associated with traditional film processing and effectively advance your practice’s technology. In an instant, imaging plates are converted and cleared for re-use, and digital images are ready for review and diagnosis. Your practice can fast track into digital imaging with the speedy, compact GXPS-500 PSP.* Acquire clear, sharp images and gain fast digital scanning while keeping the office’s familiar workflow process and preserving your past investment in x-ray equipment, whether its AC or DC.įlexible and thin, wireless PSP plates match the sizes and are positioned in the same manner as traditional film. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.Gendex GXPS-500 Digital Intraoral Phosphor Plate SystemĪll of the gain. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. In addition, customers were asked to complete and return an Acknowledgement Form by fax to 1-84.įurther questions should be directed to the Gendex Technical Support team at 1-88.ġ A record in this database is created when a firm initiates a correction or removal action. The noticed described the issue and provided a software update directed to fixing the problem. Gendex issued an "Urgent Medical Device Report" dated Mato the direct account dealers of the affected device via first class mail. There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain images that are mixed between patients. Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2 Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. System, image processing, radiological - Product Code MUH Class 2 Device Recall Gendex VixWin Platinum Imaging Software
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