Ge Hangwei Medical Systems Co., Ltd.
Ge Hangwei Medical Systems Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2024, with 2 FDA device recalls on record.
Top product codes for Ge Hangwei Medical Systems Co., Ltd.
FDA recalls by Ge Hangwei Medical Systems Co., Ltd.
- Z-0552-2024 — 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.
- Z-0553-2024 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ge Hangwei Medical Systems Co., Ltd.
- K233749 — Revolution Ascend Sliding
- K192956 — Auto Positioning
- K192686 — Revolution Maxima, Revolution Ace
- K171013 — Revolution ACT
- K160131 — OEC Elite MiniView
- K123596 — OPTIMA CT520
- K123417 — BRIVO MR355, OPTIMA MR360
- K122694 — GE 8CH FOOT ANKLE COIL
- K120778 — BRIVO MR355
- K103330 — BRIVO MR355, OPTIMA MR360
Data sourced from openFDA. This site is unofficial and independent of the FDA.