SHH — Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer Class III
FDA product code SHH covers "Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SHH
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).