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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
ZHUJI WONDER BANDAGE CO.,LTD.
Manufacturer
🇨🇳 China
Medical Diode Laser Therapy Systems
Device
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·On the market·5 countries
MED-870+
Device
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·On the market·2 countries
MED-230
Device
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·On the market·4 countries
MED-210
Device
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·On the market·4 countries
MED-810A
Device
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·On the market·2 countries
AL1
Device
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·On the market·2 countries
Medical Intense Pulsed Light Therapy Systems
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·1 device
Medical Intense Pulsed Light Therapy Systems
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·1 device
Medical Nd:YAG Laser Therapy Systems
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·1 device
Medical Fractional CO2 Laser Therapy Systems
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·1 device
MED-808
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·1 device
Medical Nd:YAG Laser Therapy Systems
Basic UDI-DI
EU MDD
·
Eu Md Class 2b
·Beijing KES Biology Technology Co.,Ltd.·1 device
No. G1 091024 0003
Certificate
MDD Annex II (excluding section 4)·Beijing KES Biology Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs
G1 091024 0003
Certificate
MDD Annex II (excluding section 4)·Beijing KES Biology Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs
G1 091024 0003
Certificate
MDD Annex II (excluding section 4)·Beijing KES Biology Technology Co.,Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
Glycosylated Hemoglobin (HbA1c) Test Kit (Immunofluorescence)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genrui Biotech Inc.·1 device
Methadone (MTD) Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beijing Jinwofu Bioengineering Technology Co., Ltd.·1 device