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Sources: EU EUDAMED, US FDA
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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
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
FDA Enforcement
Class II
·Terminated·Nucletron BV·November 1, 2017
Enterprise 1.5T, Model Number: 781145;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T R11, Model Number: 781170;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera CV, Model Number: 781107;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 0.5T Standard, Model Number: 781101;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T Power/Pulsar, Model Number: 781105;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T, Model Numbers: 781195 and 781295;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
SmartPath to dStream for 1.5T, Model Number: 782146;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T Master/Nova, Model Number: 781106;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.0T Power/Pulsar, Model Number: 781103;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
SmartPath to dStream for 3.0T, Model Number: 782145;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T Omni/Stellar, Model Number: 781104;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 3.0T Quasar Dual, Model Number: 781150;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Intera 1.0T Omni/Stellar, Model Number: 781102;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 21, 2025
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 3, 2025
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026
Philips Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·June 30, 2021