SHHClass III

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

Unknown

SHH is the FDA product code for Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer, a class III device type. FDA's definition for this code reads: "Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy)". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: SHH
Device name: Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer
FDA definition: Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).
Device class: Class III
Review panel: Unknown
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code SHH

FDA records hold no clearances under product code SHH.

Recent recalls

Product code SHH

FDA records show no recalls under product code SHH.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)