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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• Radiographic Intensifying Screen (FDA Code: EAM / 892.1960) A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.

• Radiographic Picture Archiving/Communication System

• Radiographic Video Tape Recorder

• Radiographic X-Ray Film

• Radiological Digital Image Communication System (FDA Code: LMD / 892.2020) A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.

• Radiological Digital Image Storage Device (FDA Code: LMB / 892.2010) A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.

• Radiological Image Digitizer (FDA Code: LMA / 892.2030) A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

• Radiological Image Processing System (FDA Code: LLZ / 892.2050) A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

• Radiological Multi Format Camera (FDA Code: LMC / 892.2040) A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

• Radiological Quality-Assurance Instrument (FDA Code: LHO / 892.1940) A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

• RIS (Radiology Information Systems)

• Solid State X-Ray Imager (FDA Code: MQB / 892.1680) An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Stationary X-Ray System (FDA Code: KPR / 892.1680)

• Teleradiology Devices

• Templates (FDA Code: HWT / 888.4800) A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

• Thermal Imaging Unit

• Wall-Mounted Radiographic Cassette Holder (FDA Code: IXY / 892.1880) A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.

• Web-enabled Information Systems

• X-Ray Film

• X-Ray Film Block Shelter

• X-Ray Film Cabinet

• X-Ray Film Cassette Repairs

• X-ray Film Digitizers

• X-Ray Film Duplicators

• X-Ray Film Envelopes

• X-Ray Film Flexible Blockers

• X-Ray Film Holder

• X-Ray Film Keeping Self

• X-Ray Film Loading & Unloading Table

• X-Ray Film Marking Pencils

• X-Ray Film Processors

• X-Ray Film Scanners

• X-Ray Film Scanning Software

• X-Ray Film Storage Bin

• X-Ray Film Storage Box

• X-Ray Film Storage Cabinet

• X-Ray Film Transport Caddies

• X-Ray Film Viewer

• X-Ray Solutions