Product code SHH

Device name

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

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

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

Source

FDA openFDA device classification dataset