FDA product code SHH: Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer
SHH is the FDA product code for oct imaging system with ai/ml software for adjunctive detection of breast cancer. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under SHH reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy).
Classification
| Field | Value |
|---|---|
| Device name | Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for SHH devices
openFDA lists no recalls for product code SHH.
Frequently asked questions
What is FDA product code SHH?
SHH is the FDA product code for oct imaging system with ai/ml software for adjunctive detection of breast cancer. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is SHH?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SHH
- Run a recall and safety report across every SHH manufacturer
- Watch product code SHH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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