# Fluorescence Imaging For Breast Cancer Detection
> **Product code: SAW** · Class III — High Risk (PMA approval required, life-sustaining) · Unknown · —
## Classification
- **FDA Product Code:** SAW
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** —
- **Review panel:** SU
- **Medical specialty:** Unknown
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SAW)
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