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These Portable Diagnostic Radiographic Systems are 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, 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 AMADEO M-DR mini Portable X-Ray is a fully digital X-ray system for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The AMADEO M-DR mini is used for wireless digital X-ray imaging. The device represents the straightforward combination of 510(k) exempt devices (x-ray generator, code IZO and collimator, code IZX) and already cleared digital panels and imaging software. Two different models of digital image acquisition panels are offered: PerkinElmer XRpad2 4336 or CareView 1500CW. Both of the panels and the associated software have been previously cleared by FDA (K161966 or K150929). Integration with the portable system was straightforward.

The dicomPACS® DX-R with flat panel digital imaging system is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. 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 dicomPACS®DX-R with flat panel digital imaging system consists of two components, the dicomPACS®DX-R software for viewing captured images on a Windows based computer, and one of three solid state X-ray imaging devices: Thales Pixium Portable 2430 EZ (wireless), Thales Pixium Portable 3543 EZ (wireless), or the Perkin Elmer 4336 XRpad (also wireless). The system will display high quality images in less than five seconds over a wide range of X-ray dose settings. The software has the following characteristics: The dicomPACS® DX-R software runs on an off-the shelf PC which forms the operator console. Images captured with the flat panel digital detector are communicated to the operator console via LAN or WLAN connection, depending on the model and the user's choice. dicomPACS®DX-R software uses the software API of the panel manufacturers to control the flat panels and to receive and to calibrate image data. The dicomPACS® DX-R software is an independent product for the acquisition, processing and optimization of X-ray images (raw images) provided by flat panel (DR) systems or CR systems. In general, such software is also called "console software" as it is installed on the so-called "console PC" of the imaging device. dicomPACS® DX-R carries out the image processing of the raw images provided by the particular device and provides the radiographer / X-ray assistant with optimum workflow for their work. The key difference between the modified device and our predicate device is the panels are wireless, Wi-Fi.

The dicomPACS® DX-R with flat panel digital imaging system is intended for use in generating radiographic images of human antomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. This device is intended for use by qualified medical when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

The dicomPACS®DX-R with flat panel digital imaging system consists of two components, the dicomPACS®DX-R software for viewing captured images on a Windows based computer, and one of three solid state X-ray imaging devices: Toshiba FDX4343R, Toshiba FDX3543RP, or Konica Minolta AeroDR P-11 (1417HQ). The system will display high quality images in less than five seconds over a wide range of X-ray dose settings. The software has the following characteristics: The dicomPACS® DX-R software runs on an off-the shelf PC which forms the operator console. Images captured with the flat panel digital detector are communicated to the operator console via LAN or WLAN connection, depending on the model and the user's choice. dicomPACS®DX-R software uses the software API of the panel manufacturers to control the flat panels and to receive and to calibrate image data. The dicomPACS® DX-R software is an independent product for the acquisition, processing and optimisation of X-ray images (raw images) provided by flat panel (DR) systems or CR systems. In general, such software is also called „console software" as it is installed on the so-called „console PC" of the imaging device. dicomPACS® DX-R carries out the image processing of the raw images provided by the particular device and provides the radiographer / X-ray assistant with an optimum workflow for their work.

dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data. dicomPACS® DX-R can control X-ray generators. dicomPACS®DX-R is not approved for the acquisition of mammographic image data. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using dicomPACS® and dicomPACS® DX-R are, for example, but not limited to adjustment of window leveling, rotation, zoom, and measurements. dicomPACS® and dicomPACS®DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data. dicomPACS® DX-R can control X-ray generators. The software comes in two varieties - as dicomPACS® 5.2. and as dicomPACS® DX-R 1.6. While dicomPACS® DX-R 1.6 provides some functionality like generator control, CR/DR acquisition and raw data processing, dicomPACS® does not have these functions.

dicomPACS® is a software system for the administration, archiving, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® also provides services for administering the data. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using dicomPACS® are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements. dicomPACS® is meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

dicomPACS® is a Picture Archiving and Communications System (PACS), as are the two Predicate Devices HIPAX and eFilm. All of them have been developed to acquire, store, communicate, display and process medical images, for example X-ray, CR, CT, MRI, and ultrasound images etc. They offer features (e.g. window levelling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions. dicomPACS® has a modular system architecture. It consists of the basic application dicomPACS-Viewer for image viewing and processing, the dicomControlCenter as application for image storage and communication and a number of other modules for database management, image acquisition, printing etc. dicomPACS® conforms to the DICOM (Digital Imaging and Communications in Medicine) standard. dicomPACS® is an autonomous software and involves no hardware.