Radiology
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GE Hangwei Medical Systems, Co., Ltd.
FDA-cleared AI medical device
FDA Submission Metadata
- Submission number
- K192956
- Decision date
- January 2020
- FDA panel
- Radiology
- Product code
- JAK
- Clinical task (npj)
- acquisition guidance
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.