SAW — Fluorescence Imaging For Breast Cancer Detection Class III
FDA product code SAW covers "Fluorescence Imaging For Breast Cancer Detection", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SAW
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
The combination product consists of an optical imaging agent for injection, and a fluorescence imaging device. The product is intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The imaging device is used with the imaging drug for fluorescence imaging of the lumpectomy cavity.