6,587 results
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37ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code JAK·November 5, 2024
Brivo MR355, NMRI system
FDA Recall
Open, Classified
·GE Healthcare (China) Co., Ltd.
1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area
Beijing China·Product code LNH·January 31, 2025
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations,injections or biopsy.
FDA Recall
Terminated
·GE Healthcare Beijing , Hangwei Medical Systems, Co. LTD
No. 2 Yong Chang North Rd.
Beijing Econ. & Tech. Dev. Zone
Beijing China·Product code OXO·September 18, 2013
Portable X-ray system
FDA Recall
Open, Classified
·DIGIMED CO., LTD
401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu
Seoul Korea (the Republic of)·Product code EHD·June 19, 2025
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 Recall
Open, Classified
·GE Hangwei Medical Systems, Co. LTD
West Area Bldg. 3, No.1 Yongchang North Road
1 Yongchangbeilu; Beijing Economic and Technological Development Area
Beijing China·Product code KPR·November 7, 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 Recall
Open, Classified
·GE Hangwei Medical Systems, Co. LTD
West Area Bldg. 3, No.1 Yongchang North Road
1 Yongchangbeilu; Beijing Economic and Technological Development Area
Beijing China·Product code KPR·November 7, 2023