FDA product code SAW: Fluorescence Imaging For Breast Cancer Detection
SAW is the FDA product code for fluorescence imaging for breast cancer detection. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under SAW reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for SAW devices, 1 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence Imaging For Breast Cancer Detection |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for SAW devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-07-31.
| Year | Recalls |
|---|---|
| 2025 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral
Frequently asked questions
What is FDA product code SAW?
SAW is the FDA product code for fluorescence imaging for breast cancer detection. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is SAW?
Class III. Typical premarket route: PMA.
Have SAW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-07-31.
Next steps
- Run an FDA pathway report with predicate devices for product code SAW
- Run a recall and safety report across every SAW manufacturer
- Watch product code SAW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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