7 results
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16ms
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Sources: EU EUDAMED, US FDA
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Country: China
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HHD Industrial Ltd
FDA registration
HHD Industrial Ltd·1 product·🇨🇳 China
SHENZHEN HLD DENTAL&TECHNOLOGY CO.,LTD
FDA registration
SHENZHEN HLD DENTAL&TECHNOLOGY CO.,LTD·14 products·🇨🇳 China
AmoyDx® HRD Complete Panel
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Amoy Diagnostics Co., LTD.·1 device
AmoyDx® HRD Focus Panel
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Amoy Diagnostics Co., LTD.·1 device
Surgical Gowns
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Sichuan Shuzhan New Materials Co., Ltd·1 device
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.
FDA Enforcement
Class II
·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.
FDA Enforcement
Class II
·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023