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Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all pediatric patients (birth to 21 years) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications

The Virtual C DRF-NEO system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as photo-spot and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF-NEO System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient.

Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside and outside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all patients except neonates (birth to one month) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications

The Virtual C DRF system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as multi-rad and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient. As compared to our predicate device, there are three main changes: The digital receptor panel become a DRTECH brand panel, the generator changes from Sedecal to Source-ray, and and the collimator is changed from Colimar to a PortaVision "Machine Vision" collimator. An initial report was submitted for that collimator.

Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, chest, abdomen, extremities. The device may be used for other imaging applications on all patients except pedian the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (RX Only)

The MobileRay Pulse SE system is a radiographic multi-rad, and fluoroscopic digital mobile X-Ray system that is designed for all pediatric and adult patients during diagnostic, surgery, and interventional procedures. The systems include (1) an x-ray source consisting of a X-Ray generator, X-Ray tube, and x-ray collimator, (2) a portable digital imaging system consisting of a wired and/or wireless flat panel digital detector, workstation software to acquire and process digital images in radiographic, multi-rad, and fluoroscopic modes, a laser SSD measuring system to accurately measure the distance between the X-ray tube focal spot and the patient, software which calculate radiation skin dose for KVp, mAs and SSD selected for the patient weight and body part being examined, a computer, mouse, keyboard, and image display monitor, or a laptop computer and (3) a mobile cart. The device does not incorporate a mechanically C-Arm or other mechanically device to ensure the x-ray source and flat panel detector are aligned. The device incorporates an electronic X-ray source and flat panel detector alignment system to comply with FDA regulation 21 CFR 1020.31 (g) (1). The system incorporates an automatic X-ray beam limited device to comply with FDA regulation 21 CFR 1020.32 (ii) (ii). There are several advance motion sensing technologies available to accurately determine if the Xray source is aligned to the flat panel detector. The device incorporates a radiation inhibit safety circuit to prevent the emission of radiation if the X-ray source is not aligned to the detector and to immediately shut down emission of radiation if for whatever reason the X-ray source is no longer aligned to the detector within the predetermine tolerance of FDA regulation 21 CFR 1020.31 (g) (1). The portable x-ray generator employed is a slightly modified version of the one cleared in K121410.

This device is intended for use in generating radiographic images of neonatal anatomy. It is intended to replace radiographic film/ screen or CR systems in neonatal general-purpose diagnostic procedures. This device is not intended for mammography applications.

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The NeoRay DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy, it is specifically optimized to operate within the Neonatal environment. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

The NeoRay DDR 2520 Digital Imaging System is a portable X-Ray system comprised of a portable digital radiographic imaging system, an X-Ray generator/collimator system, and a mobile stand.