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Sources: EU EUDAMED, US FDA
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Country: Netherlands
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FIBRE INTERSPACED X-RAY GRID
FDA 510(k)
FDA Class 1
·Radiology
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.
FDA Enforcement
Class II
·Terminated·Claymount Assembli·July 9, 2014
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.
FDA Enforcement
Class II
·Terminated·Claymount Assembli·July 9, 2014
GRI-Alleset Limited B.V.
Importer
🇳🇱 Netherlands·1 Manufacturer
GRI-Alleset Limited B.V.
Authorized representative
🇳🇱 Netherlands·1 Manufacturer·2024 Devices
Philips Medical Systems Nederland B.V.
Authorized representative
🇳🇱 Netherlands·21 Manufacturers·1029 Devices
PureCE B.V.
Authorized representative
🇳🇱 Netherlands·38 Manufacturers·468 Devices
CEpartner4U
Authorized representative
🇳🇱 Netherlands·160 Manufacturers·5787 Devices