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The DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) of the following anatomies/procedures: - · Positioning fluoroscopy procedures - · Gastro-intestinal examinations - · Urogenital tract examinations - · Angiography It is intended to replace fluoroscopic images obtained through image intensifier technology. In addition, the system is intended for project radiography of all body parts. The DR 800 is not intended for manimography applications.

Agfa HealthCare's DR 800 is an image-intensified fluoroscopic x-ray system (product code JAA) intended to capture images of the human body. The DR 800 is a floor-mounted R/F system that consists of a tube and operator console with a motorized tilting patient table and bucky with optional wall stand, FLFS overlay and ceiling suspension. The new device uses Agfa's NX workstation with MUSICA Dynamic™ image processing and flat-panel detectors for digital and wide dynamic range image capture. It is capable of replacing other direct radiography, image intensifying tubes and TV cameras, including computed radiography systems with conventional or phosphorous film cassettes.

Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used. Agfa's DX-D Imaging Package is not indicated for use in mammography.

Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture general radiography images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors. This submission is to add the DR14e and DR17e Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. Agfa's DR 14e and DR 17e wireless panels are currently marketed by Innolux as RIC 35C/G and RIC 43C/G, which is one of the predicates for this submission. Principles of operation and technological characteristics of the new and predicate devices are the same. There are no changes to the intended use/indications of the device. The new device is physically and electronically identical to both predicates, K161368 and K162344. It uses the same workstation as predicate K161368 and the same flat panel detectors to capture and digitize the images as predicate K162344.

Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements. When images are reviewed and used as an element of diagnosibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use. XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.

Enterprise Imaging XERO Viewer is a web based software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. XERO Viewer enables authenticated users to search for and display patient studies (reports and images) using a web browser, user's do not need to download or install any additional software or plug-ins to use XERO Viewer. It is the successor to Agfa's ICIS View predicate (K143397) and adds the following new functionality: it adds Xtended study viewing) desktop diagnostic support for additional modalities, supports Xtend 3D visualization and ECG mobile (Full Fidelity) diagnostic support utilizing the newer iPad version.

Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be used. Agfa's DX-D Imaging Package is not indicated for use in mammography.

Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors. This submission is to add the DR10s and DR14s Flat Panel Detectors to Agfa's DX-D Imaging Package portfolio. The DX-D Imaging Package with the DR 10s and DR 14s wireless panels will be labeled as the Pixium 2430EZ and Pixium 3543EZ. DR 10s and DR 14s are commercial trade names used by Agfa HealthCare for marketing purposes only. Principles of operation and technological characteristics of the new and predicate device are the same. There are no changes to the intended use/indications of the new device is physically and electronically identical to the predicate, K142184. It uses the same workstation and the similatorphotodetector flat panel detectors to capture and digitize the images as predicate K142184.

The Volume Viewing software is a visualization package for PACS workstations. It is intended to support the medical professional in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital image processing tool, with optional functionality to facilitate visualization and measurement of vessel features. Other optional functionality is intended for the registration of anatomical (CT) on a second CT dataset or on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumour measurements, and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI), has a dedicated tool set for lung lesion segmentation, quantification and follow-up of lesions selected by the user and provides tools to define and edit paths such as centerlines through structures, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such centerline. Caution: Web-browser access is available for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care.

IMPAX Volume Viewing is a general purpose medical image processing tool for the reading and analysis of 3D image datasets. It is also intended for the registration of anatomical (CT) image data onto functional (MR) data to facilitate the comparison of various lesions. Volume and distance measurements facilitate the quantification of lesions and the analysis of both soft and hard tissue. A variant of the software also provides web-browser access for review purposes. Images accessed through a web-browser (via a mobile device or by other means) should not be used to create a diagnosis, treatment plan, or other decision that may affect patient care. The new device is similar to the predicate devices. All are PACS system accessories that allow the user to view and manipulate 3D image data sets. This new version adds a dedicated tool set for lesion management and flythrough visualizations rendered along a centerline for endoscopic view of vessels and airways. Principles of operation and technological characteristics of the new and predicate devices are the same.

The DR 600 is a GenRad X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adults and pediatric patients. Applications can be performed with the patient in sitting, standing or lying position. The DR 600 is not intended for use in Mammography applications.

Agfa's DR 600 is a solid state x-ray system, a direct radiography (DR) system (product code MOB) intended to capture images of the human body. The device is a combination of a conventional x-ray system with digital image capture. The DR 600 is a ceiling mounted tube and operator console with a motorized patient table and/or wall stand. The DR 600 uses Agfa's NX workstation with MUSICA2 ™ image processing and flat-panel detectors of the scintillatorphotodetector type (Cesium Iodide - CsI or Gadolinium Oxysulfide - GOS). It is compatible with Agfa's computed radoigraphy systems as well.

ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer. Users may access the product directly via a web-browser, select mobile devices, healthcare portal or within the Electronic Medical Record (EMR). ICIS® View allows users to perform basic image manipulations and measurements (for example window/level, rotation, zoom, and markups). ICIS® View can optionally be configured for Full Fidelity mode, which is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports. ICIS® View Full Fidelity is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View full fidelity is not intended for the display of digital mammography images for diagnosis.

Agfa's ICIS® View system is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. The new device is substantially equivalent to the predicate devices (K103785, K022292, & K111164). It is a multidisciplinary viewer that allows the user to securely access patient images and reports from any PACS or vendor-neutral archive. Images and reports can be viewed directly via a web-browser, select mobile device, healthcare portal or Electronic Medical Record (EMR). The new device includes some of the clinical tools of the predicate devices specifically the functionality to retrieve original lossless renditions of stored images for diagnostic purposes. The optional Full Fidelity functionality allows the retrieval of original lossless renditions of stored CR, DX, CT, MR, and US images for diagnostic purposes on select mobile devices or FDA cleared display monitors when there is no access to a full workstation.

IMPAX Agility is a Picture Archiving and Communications System (PACS). It provides an interface for the acquisition. display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. IMPAX Aglity is intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data. MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling and image registration can be used to enhance image viewing. Automatic spine labelling provides the capability to semiautomatically label vertebrae or disks. As a comprehensive imaging suite, IMPAX Agility integrates with servers, archives. Radiology Information Systems (RIS), Hospital Information Systems (HIS), reporting and 3rd party applications for customer specific workflows. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for mammographic use.

Agfa's IMPAX Agility system is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the acquisition, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. The new device is substantially equivalent to the predicate devices (K111945, K133135, & K123920). It is a comprehensive PACS system that allows the user to view and manipulate 3D image data sets. The new device includes some of clinical tools of the predicate devices specifically the functionality to perform image registration, and automatic spine labeling. The image registration functionality allows comparison studies to be registered with active study data to align them for reading. Registration only works for volumetric CT and MR data. Segmentation of volumetric datasets allows the automatic removal of bones and the CT table. Bone and table removal is only available for CT datasets. Users can also manually define parts of the volume which should be removed, as well as highlight certain structures in volumes. Automatic spine labeling tools provide the ability to label the vertebrae or the intervertebral discs of the spine. Automatic spine labeling automatically calculates the position of the vertebrae or discs after the user selects and labels an initial starting point. The user is required to confirm the automatic placement of the labels. Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices. Laboratory data, stability and performance assessments, usability tests, and functionality evaluations conducted with qualified radiologists confirm that performance is equivalent to the predicates.

Agfa's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The DX-D Imaging Package may be used wherever conventional screen-film systems may be be used. Agfa's DX-D Imaging Package is not indicated for use in mammography.

Agfa's DX-D Imaging Package is a solid state flat panel x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa's NX workstation and one or more flat-panel detectors. This submission is to add the DX-D40C/G Flat Panel Detector to Agfa's DX-D Imaging Package portfolio. Agfa's DX-D40C/G is currently marketed by Vieworks as the ViVIX-S Wireless Panel (K122865), which is one of predicates for this submission. Principles of operation and technological characteristics of the new and predicate devices are the same. The new device is physically and electronically identical to both predicates, K121095 and K122865. It uses the same workstation as predicate K121095 and the same scintillatorphotodetector flat panel detectors to capture and digitize the images as predicate K122865.

Agfa HealthCare's DX-D Imaging Package is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy for adult, pediatic and neonatal examinations. The DX-D Imaging Package may be used wherever conventional screen-film systems, CR or DR systems may be used. Agfa HealthCare's DX-D Imaging Package is not indicated for use in mammography.

Agfa HealthCare's DX-D Imaging Package is a solid state x-ray system, a direct radiography (DR) system (product code MQB) intended to capture images of the human body. It is a combination of Agfa HealthCare's NX Workstation, one or more flat-panel detectors, needlephosphor detectors for direct radiography (DR) applications. DX-D Imaging Package uses the NX Workstation to process data utilizing Agfa HealthCare's MUSICA image processing software, which includes optional image processing algorithms for adult, pediatric and neonatal images that were previously cleared for use in Agfa HealthCare's DX-D Imaging Package (K122736). The acronym MUSICA stands for Multi-Scale-Image-Contrast-Amplification. MUSICA acts on the acquired images to preferentially enhance the diagnostically relevant, moderate and subtle contrasts. This submission is to obtain clearance for Agfa HealthCare to market the DX-D Imaging Package using a minimum of 50% dose reduction marketing claims. Principles of operation and technological characteristics of the DX-D Imaging Package and predicate devices are the same. The DX-D Imaging Package is physically and electronically identical to the predicate K122736 since it is the same device; however, Agfa HealthCare would like to include a minimum of 50% dose reduction claims for marketing purposes. It uses the same workstation and same scintillator-photodetector flat panel detectors, needle-phosphor detectors and cassettes, or photo-stimulable imaging plates to capture and digitize the image.