114 results
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Sources: EU EUDAMED, US FDA
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SHANGHAI MAY SKIN INFORMATION TECHNOLOGY CO., LTD.
FDA registration
SHANGHAI MAY SKIN INFORMATION TECHNOLOGY CO., LTD.·5 products·🇨🇳 China
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
Tianjin New Bay Bioresearch Co., Ltd.
Manufacturer
🇨🇳 China·22 Basic UDI-DIs·22 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
Shanghai Moon Bay Medical Instrument Co., Ltd.
Manufacturer
🇨🇳 China
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·August 19, 2020
OPMI LUMERA 300, REF 6137
FDA Enforcement
Class II
·Ongoing·Carl Zeiss Suzhou Co., Ltd.·November 1, 2023
Zhuji Pengtian Medical Instrument Co.,Ltd
Manufacturer
🇨🇳 China·3 Importers
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·August 19, 2020
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·August 26, 2020
Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B
FDA Enforcement
Class I
·Ongoing·DEWEI MEDICAL EQUIPMENT CO LTD·December 14, 2022
uCT 760 System, Computed Tomography X-ray System
FDA Enforcement
Class II
·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·July 15, 2020
uCT 530 Computed Tomography X-Ray System
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·July 8, 2020
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·October 19, 2022
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
FDA Enforcement
Class II
·Terminated·NEUSOFT MEDICAL SYSTEMS IMP & EX·February 13, 2019
Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·July 29, 2020
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
FDA Enforcement
Class I
·Ongoing·Flexicare Medical (Dongguan) Ltd.·August 13, 2025