Radiology
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
NinePoint Medical, Inc.
FDA-cleared AI medical device
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
FDA Submission Metadata
- Submission number
- K182616
- Decision date
- November 2018
- FDA panel
- Radiology
- Product code
- NQQ
- Clinical task (npj)
- quantification/feature localization
- 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.