Radiology
ClearRead CT
RIVERAIN TECHNOLOGIES, LLC
FDA-cleared AI medical device
To assist radiologists in the review of multi-slice computed tomography (msct) exams of the chest and highlight potential nodules that the radiologist should review. A computer aided diagnosis, lung computed tomography system is a class 3 device under product code NRR.
FDA Submission Metadata
- Submission number
- K161201
- Decision date
- September 2016
- FDA panel
- Radiology
- Product code
- OEB
- Clinical task (npj)
- detection
- 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.