SHH

Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

Product code: SHH
Device name: Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification definition

Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SHH

Classification and pathway per current FDA publications. Data from openFDA (CC0).