Radiology
ScreenDx
Imvaria, Inc
Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
FDA Submission Metadata
- Submission number
- K241891
- Decision date
- January 2025
- FDA panel
- Radiology
- Product code
- QWO
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.
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