1 device · 1 company · 2026
Product code SHH: Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer
1 device under product code SHH, 2026, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer. Intended as an adjunctive tool for intraoperative imaging and detection of cancer in breast tissue during excisional breast surgery (e.g., lumpectomy). MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Claire OCT SystemP250008 · PMA | Perimeter Medical Imaging Ai, Inc. | General and Plastic Surgery | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.