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Sources: EU EUDAMED, US FDA
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ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·DIAGAST·1 device
ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DIAGAST·3 devices
The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.
FDA Enforcement
Class II
·Terminated·EOS Imaging·April 21, 2021
Implicity
Manufacturer
🇫🇷 France·3 Basic UDI-DIs·3 Devices
Contact Sécurité
Manufacturer
🇫🇷 France·2 Basic UDI-DIs·10 Devices
Eurobio Scientific
Manufacturer
🇫🇷 France·20 Basic UDI-DIs·44 Devices
LOGO SILVER
Manufacturer
🇫🇷 France
AL/GER
Manufacturer
🇫🇷 France
CIDELEC
Manufacturer
🇫🇷 France
Botdesign
Manufacturer
🇫🇷 France
FLEURANCE NATURE
Manufacturer
🇫🇷 France
UGIN DENTAIRE
Manufacturer
🇫🇷 France
DICARTECH SAS
Manufacturer
🇫🇷 France
CREATION XXI
Manufacturer
🇫🇷 France·6 Basic UDI-DIs·28 Devices
Escoffier Frères
Manufacturer
🇫🇷 France
SIGVARIS SAS
Manufacturer
🇫🇷 France
MPTronic
Manufacturer
🇫🇷 France·6 Basic UDI-DIs·8 Devices
MELISANA PHARMA
Manufacturer
🇫🇷 France
Artis CF
Manufacturer
🇫🇷 France·1 Basic UDI-DI·1 Device
ARCHEON
Manufacturer
🇫🇷 France