21 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 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: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·July 30, 2014
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·April 17, 2013
IMPAX RIS QDOC 5.8
FDA Enforcement
Class II
·Terminated·AGFA Corp.·February 12, 2014
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·April 17, 2013
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·August 1, 2012
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
FDA Enforcement
Class II
·Terminated·AGFA Corp.·August 22, 2012
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·June 4, 2014
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
FDA Enforcement
Class II
·Terminated·AGFA Corp.·August 29, 2012
CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·March 27, 2013
AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 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: chest, abdomen, and other body parts.
FDA Enforcement
Class II
·Terminated·AGFA Corp.·June 12, 2013
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
FDA Enforcement
Class II
·Terminated·AGFA Corp.·October 30, 2013
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
FDA Enforcement
Class II
·Ongoing·AGFA Healthcare Corp.·December 31, 2025
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
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
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
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