Product code SAW

Device name
Fluorescence Imaging For Breast Cancer Detection
Medical specialty
Unknown
Device class
3
Review panel
SU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset