General_plastic_surgery
DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
Dilon Medical Technologies, Ltd.
FDA-cleared AI medical device
As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.
FDA Submission Metadata
- Submission number
- P110014
- Decision date
- December 2012
- FDA panel
- General and Plastic Surgery
- Product code
- OEE
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.