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The EVA SELECT Digital Dental Imaging System is intended to be used with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.

The EVA SELECT System (previously named the EVA System) has been modified to incorporate a new sensor component. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent EVA Digital Dental Imaging System. The modifications are limited to changing the sensor from a proprietary design to a commercially available sensor which is already used in at least 2 devices with pre-market clearances (K112380 and K102456). As with the original EVA Sensor, the CMOS sensor when exposed to radiation uses a scintillator to indirectly capture the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized and sent to a computer via a USB interface. The images are then available for display on a computer monitor screen.

The NewTom VG Computed Tomography X-ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The NewTom VG accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings.

The NewTom VG Computed Tomography X-Ray System (NewTom VG) is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images. It then reconstructs a three-dimensional matrix of the examined volume and produces two-dimensional views of such volume, displaying both two- and three-dimensional images. The NewTom VG can measure distances and thickness on two-dimensional images. Such images can be printed or exported on magnetic and optical media. The NewTom VG hardware, including a scanner unit (comprised of an X-ray source, flat panel detector and a motorized arm) and a control box. facilitates the acquisition of a full X-ray sequence by the device software. The NewTom VG software runs on an x86 architecture based workstation. The NewTom VG reconstructs a three-dimensional model of x-ray images similar to the threedimensional model obtained using the parent NewTom 3G Computed Tomography X-Ray System (NewTom 3G).

The EVApan Digital / K1VSM2000 System is intended to be used with standard dental panoramic systems such as the Villa Strato X (K002432) X-ray system and Dental Image Management Software computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support by qualified dental professionals. The EVApan Digital / K1VSM2000 Dental Panoramic Sensor is intended to be used with the STRATO Panoramic X-ray System (K002432), manufactured by VILLA SISTEMI MEDICALI S.P.A (registration number 8021091) and a computer work station for Dental Panoramic Radiographic Imaging.

The EVApan Digital K1VSM2000 System is a digital imaging system in which traditional dental X-ray film has been replaced by a solid-state sensor. The sensor, when exposed to radiation, captures the image in the form of a charge pattern on its surface. The resulting electronic signals are digitized and sent to a computer screen for image presentation.

The EVA Digital Dental Imaging System is intended to be used with standard digital dental X-ray systems and computer stations for system operation, archive data storage, input capture and enhancement, and patient data and support.

The EVA System (previously named the Sens-A-Ray System) has been modified to incorporate a new sensor component and docking station. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent Sens-A-Ray System described in K923067. The modifications are limited to changing the sensor from a CCD Sensor to a Complimentary Metal Oxide Semiconductor (CMOS) sensor and adding a docking station. As with the original Sens-A-Ray Sensor, the CMOS sensor when exposed to radiation captures the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized by a processor and sent to a computer screen for image presentation. The EVA System Sensor and supporting electronics are identical in intended use and fundamental technology to the parent Sens-A-Ray Sensor and supporting electronics.

This product is used as a surface sealant for indirect composites.

A single bottle glaze for use on indirect resin composite restorations.

The AFP Imaging Sens-A-Ray Digital Dental X-Ray System with ProImage Software is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support. It is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support.

The ProImage Software is essentially identical to the Sens-A-Ray software described in K923067. The AFP Imaging ProImage Software and Sens-A-Ray System are intended to be used in conjunction with standard X-Ray systems. X-Ray images are sent by a digitized processor to a computer screen for image presentation. As with the Sens-A-Ray Software, the ProImage Software provides and controls the following functions: A patient/image database, which logs a patient's statistical and image data, Image exposure, Image storage, Image processing, Image retrieval and post-processing, Image hardcopy. The modifications to the Sens-A-Ray software involve enabling video images and intraoral images to be manipulated within the same software package. The minor modifications involve better database search and structure to allow the user to catalog patient images in an easier and more intuitive format. The other improvements are feature improvements resulting from user input. The feature improvements include: Colorizing image, auto-contrast, re-expose, and "view histogram" functions, Importing multiple images and adjusting the size and resolution of images, Adding an endodontic mode which allows full-screen X-rays. The modifications above were made to accommodate more advanced digital X-ray systems and to provide the user with better imaging capabilities within a single software package. These modifications remain within the scope of the intended use and fundamental technology of the original Sens-A-Ray system. The ProImage Software is intended for use with a sensor unit, image unit, and image grabber that were previously cleared under K923067. The ProImage Software is also compatible with the AFP IntraOral camera, subject of K922942 and other legally marketed intraoral cameras.

The ScanARay Advanced Computerized X-Ray System is intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral exposures.

The ScanARay Advanced Computerized X-Ray System is a filmless system intended for digital intraoral and extraoral radiography using a phosphor storage screen. It enables the dentist to scan or import images for display, review or storage in a database. It consists of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a user-provided personal computer.