SAW · Fluorescence Imaging For Breast Cancer Detection
· Class 3
Overview
| Product Code | SAW |
|---|---|
| Device Name | Fluorescence Imaging For Breast Cancer Detection |
| Device Class | Class 3 |
| Review Panel |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230014 | Lumicell Direct Visualization System (DVS) | Lumicell, Inc. | Apr 17, 2024 | APPR |
Top Applicants
- Lumicell, Inc. — 1 clearance
