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ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)

Basic UDI-DI
EU IVDR · 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