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ViZion DR is intended for digital image capture use in general radiographic examinations for adult and pediattic, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis and extremities.

The ViZion DR system represents the straightforward intearation of two cleared devices. ViZion DR is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) K090742 (Samsung Flat-Panel X-Ray Detector), Samsung Mobile Display Co., Ltd. (this is the 510(k) for the flat panel detector) and Viztek's proprietary OPAL-RAD PACS image viewing and acquire interface software technology, (K063337) which incorporates state of the art object-oriented software and connectivity. ViZion is designed to perform digital radiographic examinations in replacement for conventional film. This integrated platform provides the benefits of PACS with the with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the Viztek PACS and Samsung FPD were not changed.

This digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremittes, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Excludes fluoroscopy, angiography, and mammography.

This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension OR a U-Arm, along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. Models: Model DR3000 (U-arm single detector) and Model DR4000 (dual detector-ceiling suspension and table and upright bucky) and DR1000 single detector (standing bucky and ceiling suspension. The digital panel is the Pixium 3543pR (K090625) and the digital subsystem is the SmartRad, CMT Medical Technologies, K003438.

This digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremitics, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension OR a U-Arm, along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 K V or 40 - 150 k V with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. Models: Model DR3000 (U-arm single detector) and Model DR4000 (dual detector-ceiling suspension and table and upright bucky) and DR1000 single detector (standing bucky and cciling suspension. The digital subsystem is the SmartRad (CMT Medical Technologies) K003438.

Opal-RAD™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

Opal - RAD is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities, and offer an interface that users find to be quite intuitive after some initial learning. The Opal-RAD applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, and many others. These images can be viewed, manipulated, annotated, transmitted to other facilities, printed, animated and stored using the Opal-RAD suite. The device is designed to be deployed over conventional networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images.