LSI 2025
Indications for Use Disclosures
S-Series OCT
The S-Series OCT is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.
The S-Series OCT has 510(k) clearance under a general indication and has not been evaluated by FDA specifically for use in breast tissue, breast cancer, other types of cancer, margin evaluation, and reducing re-excision rates. The safety and effectiveness of these uses has not been established.
For full information on unapproved/off-label uses, visit: perimetermed.com/disclosures or contact medicalaffairs@perimetermed.com
B-Series OCT
The Perimeter B-Series OCT System is an adjunctive three-dimensional imaging tool which provides volumetric cross-sectional, real-time depth visualization, coupled with an artificial intelligence computer aided detection algorithm which identifies and marks focal areas suspicious for breast cancer and is used concurrently with physician interpretation of the images. The B-Series OCT is intended for use in conjunction with other standard methods for evaluation of the margins of an excised lumpectomy specimen during surgical procedures in patients with a biopsy-confirmed diagnosis of breast cancer.
Perimeter B-Series OCT is not available for sale in the United States. CAUTION – Investigational device. Limited by U.S. law to investigational use.