Profile: Agfa Healthcare Corp develops, manufactures and markets analog & digital imaging systems, mainly for the healthcare & specialty industries. We supply both analogue and digital imaging solutions and an innovative range of diagnosis & communications systems, including computed radiography & digital networks for hospitals. Our equipment, consumables and services are targeted to different departments & include comprehensive information systems tailored to the needs of each hospital. Our IMPHAX® CV now interfaces with Cedaron's CardiacCare™ solutions for cardiology outcomes data collection and national database reporting. This offering allows clinical users to collect procedural information and automatically import the required data to the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR), the Society for Thoracic Surgeons (STS) National Database, and a number of state & provincial registries & databases. Our IMPAX® CV delivers innovative features, including advanced image management functionalities, structured reporting and secure enterprise-wide access to diagnostic data.

The company has revenues of USD 500 Million to 1 Billion, has ~28000 employees and is ISO 9000, ISO 9001, ISO 9002, ISO 9003, CE certified.

FDA Registration Number: 1065979

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• Advanced X-Ray Solutions

• Angiographic X-Ray System (FDA Code: IZI / 892.1600) An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Automatic Daylight X-Ray Film Handling Unit

• Automatic Radiographic Film Processor (FDA Code: IXW / 892.1900) An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

• Bench Mounted Hopper for X-Ray Film

• Blue Rare Earth X-Ray Film

• Cassettes & Screens

• Cine Film Processor (FDA Code: IXX / 892.1900)

• Computed Radiography Kits

• Computed Tomography X-Ray System (FDA Code: JAK / 892.1750) A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Contract Manufacturers

• Dark Room Equipment

• Dental X-Ray Film

• Dental X-Ray Solutions

• Dictation Systems

• Digital Extraoral Source X-ray System (FDA Code: MUH / 872.1800) An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

• Digital Imaging Systems

• Digital X-Ray Solutions

• ECG Analyzer

• Electrocardiograph (FDA Code: DPS / 870.2340) An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

• Electrostatic X-Ray Imaging System (FDA Code: IXK / 892.1630) An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Film

• Film Holders & Cassettes

• Film Processor Chemical

• General Medical Supplies

• Green Sensitive Rare Earth X-Ray Film

• Image Archiving Systems

• Image Archiving Systems Connectivity, Bi-directional

• Image Archiving Systems Connectivity, Quick View DICOM viewer

• Image Archiving Systems DICOM connectivity

• Image Archiving Systems DICOM, HL-7 and SQL

• Image Archiving Systems Image Archiving Tools

• Integration Services

• Laboratory Information Management System

• Laser (Dry & Wet) Imagers

• Mammographic X-Ray System (FDA Code: IZH / 892.1710) A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Mammography Devices

• Medical Cathode-Ray Tube Display (FDA Code: DXJ / 870.2450) A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.

• Medical Imaging

• Medical Imaging Kits

• Mobile X-Ray Solutions

• Non-Fetal Ultrasonic Monitor (FDA Code: JAF / 892.1540) A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Picture Archiving & Communications Systems

• Programmable Diagnostic Computer (FDA Code: DQK / 870.1425) A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

• Radiographic Film (FDA Code: IWZ / 892.1840) Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.

• Radiographic Film Cassette (FDA Code: IXA / 892.1850) A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

• Radiographic Film Marking X-Ray System (FDA Code: JAC / 892.1640) A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.

• Radiographic Film/Cassette Changer (FDA Code: KPX / 892.1860) A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.

• Radiographic Grid (FDA Code: IXJ / 892.1910) A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.

• Radiographic Image Analysis Computer