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The InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information.

The InfiMed Dental System is an image acquisition and management system. Its capabilities include: Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Injection Device (CID) sensor custom designed for the application. Images can be directly printed and displayed on standard S-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal computer.

The provided text from the FDA 510(k) premarket notification does not contain information regarding acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, or expert qualifications for the InfiMed Dental System.

The document is a letter from the FDA to InfiMed, Inc. confirming that their device, the "InfiMed Dental System" (K962422), has been found substantially equivalent to legally marketed predicate devices. It outlines the regulatory class, procode, and general controls applicable to the device.

The "Indications for Use" section describes the device's functionality: an image acquisition and management system for filmless radiographs and/or color dental images, consisting of components to acquire, store, display, and print these images with patient information. It details how color images are acquired (from a standard S-video color camera) and radiographs are acquired (from a Charge Injection Device (CID) sensor). It also mentions the capability for direct printing/display or transfer to a personal computer for acquisition, storage, patient data input, image processing, display, and printed reports.

Therefore, I cannot provide the requested information based on the given document.

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