General_plastic_surgery

NEVISENSE

SCIBASE AB

FDA-cleared AI medical device

FDA Submission Metadata

Submission number
P150046
Decision date
June 2017
FDA panel
General and Plastic Surgery
Product code
ONV

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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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.