BEUDAMED
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    IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LMD·December 11, 2007

    Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·January 16, 2012

    IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpretation, and results distribution. The IMPAX 6.5 Client focuses on the integration of PACS, RIS and Speech applications into a single delivery of information. A single IMPAX 6.5 Client application can be used by a range of users on any appropriate, networked workstation they have access to.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 5, 2011

    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·April 5, 2017

    AGFA DX-D 100 is a mobile digital radiography x-ray system

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·June 17, 2015

    IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·November 25, 2015

    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

    FDA Enforcement
    Class III ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·July 5, 2017

    Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

    FDA Enforcement
    Class III ·Terminated·AGFA Healthcare Corp.·December 24, 2014

    IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) 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.

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·July 22, 2015

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Enforcement
    Class III ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·August 20, 2014

    DX-D600 - DXD Imaging Package

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·April 12, 2017

    Agfa Healthcare NX 3.0.8950 Imaging Processing Software

    FDA Enforcement
    Class II ·Terminated·AGFA Healthcare Corp.·July 26, 2017

    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code LLZ·December 22, 2016

    Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IWZ·October 24, 2014

    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code KPR·July 2, 2014

    Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IWZ·July 16, 2014

    AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IZL·January 20, 2016

    Agfa Healthcare NX 3.0.8950 Imaging Processing Software

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code MQB·December 21, 2016