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

SHH · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: SHH
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: SU
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown