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The OTC DDR is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).

This submission is for a MODIFICATION to our predicate device. Instead of supplying a straight arm tube stand we be supplying an overhead tube crane. The imaging components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The OTC DDR features the latest developments in high-technology construction and design, including the potential for Dynamic Digital Radiography (DDR), making it possible to rapidly capture sequential radiographs in a single exam. It consists of the following subassemblies: X-ray tube, positioner, automatic exposure control, collimator, X-rav generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The ULTRA software was most recently cleared in K214012 and has not been changed from the cleared version

This device is indicated for use in generating radiographic images of human anatomy. It is intended to a replace radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.

Konica Minolta Universal DR 1748 combines components into a complete digital x-ray system upgrade kit, including software and digital radiography panel.

The Straight Arm DDR is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).

This submission is for a MODIFICATION to our predicate device. Instead of supplying a "U-shaped" arm we will be supplying a "Straight" arm. The other components of the system remain unchanged. This is a versatile digital radiography system that facilitates workflow and provides exceptional dose efficiency. The Straight Arm DDR features the latest developments in high-technology construction and design, including the potential for Dynamic Digital Radiography (DDR), making it possible to rapidly capture sequential radiographs in a single exam. It consists of the following subassemblies: X-ray tube, positioner, automatic exposure control, collimator, X-ray generator, patient mobile table, and digital x-ray acquisition station with ULTRA software. The straight arm assembly was originally cleared in K062335. The ULTRA software was most recently cleared in K212291 and has not been changed from the cleared version.

EXA™ is a software device that receives digital images and data from various sources (i.e. CT 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 cleared by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

EXA™ 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. (Not intended for use on mobile devices) The EXA™ applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, MG and many others. These images can be viewed, annotated, transmitted to other facilities, printed, animated and stored using the EXA™ PACS suite.

The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR™ AU System Advanced U-Arm with Static Digital Radiography is indicated for use by qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic static and serial radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position (not for mammography).

The proposed System is a digital radiography diagnostic system that has the capability of obtaining two modes (static mode and dynamic modes) of radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Images may be obtained with the patient sitting, standing, or lying in the prone or supine position. It is not intended for mammographic use. The system is configurable in two options. Both are exactly the same with the exception of the option to select one of two flat panel detectors. One configuration, referred to as KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography contains a HD/FNB flat panel and the other configuration, referred to as KDR™ AU System Advanced U-Arm with Static Digital Radiography a HQ/KDR panel. The technological feature of each flat panel detector is described below. The proposed system is a compact, floor and wall mounted radiographic system with proprietary ULTRA software and DICOM 3 connectivity. The system consists of a combination of several components. The System's hardware consists of the 3 kev components: 1) A floor and wall-mounted Positioner (also referred to as a stand) 2) A generator 3) An off-the-shelf computer with proprietary software (also referred to as an acquisition workstation) The positioner has a swivel arm that has several rotating and linear movements, and movement controls including an information screen. Mounted on the positioner are: a) A collimator, b) An X-ray tube c) An Automatic Exposure Control (AEC) d) A flat panel detector (There are 2 configurations available for the end user to select. The KDR™ AU-DDR System Advanced U-Arm with Dynamic Digital Radiography contains a HD/FNB flat panel detector capable of obtaining both static and dynamic images and the KDR™ AU System Advanced U-Arm with Static Digital Radiography, which contains the HQ/KDR flat panel detector capable of obtaining static images only. Hardware accessories include: 1) A mobile patient table 2) Stitching stand 3) Weight bearing stand Optional Hardware accessories include: 1) Motorized height adjustable table 2) 3 knob collimator 3) Dose area product meter 4) Advanced weight bearing stand The proposed system has a proprietary ULTRA software as the central interface of the system. The software for the proposed system enables users to acquire static and dynamic images. There are two modes within the software package of the proposed system, "static mode," which may be used to generate, a single frame of radiographic images captured at a single time and "dynamic mode" (or "Dynamic Digital Radiography," abbreviated "DDR,") which generates multiple frames in a single series, presenting the physician with a diagnostic view of dynamic density and anatomic motion without using fluoroscopy or cine. The number of images acquired with the proposed system are limited to 300 compared with flouroscopy or cine, which do not limit the number of images (Note: only the configuration with the HD/FNB flat panel detector is capable of obtaining both static and dynamic images. The other configuration may only obtain static images). The system is also capable of quickly assuming a preprogrammed position when a new exam is selected, saving time when positioning the equipment. This is referred to as "auto positioning," and made possible by the positioner and image processing software working together.