S-Series OCT System Intended Use Disclosures:
Intended Use: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.
Unapproved Uses: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 https://perimetermed.com/disclosures or contact medicalaffairs@perimetermed.com.
Disclaimer:
Case reviews in this presentation are provided for informational purposes only and are examples of a specific use of OCT used for margin evaluation in lumpectomy surgeries. OCT has not yet been evaluated by FDA for this specific use. Detection, characterization, and interpretation of the OCT images is performed by users in accordance with their professional training and expertise with the OCT imaging modality.
This webinar is supported by Perimeter Medical Imaging through a marketing grant. It is not part of the official American Society of Breast Surgeons educational programming and no AMA PRA Category 1 Credits™ have been assigned to them by the ASBrS.