# P250008: Claire™ OCT System

- Pathway: PMA
- Applicant: Perimeter Medical Imaging Ai, Inc.
- Decided: Mar 3, 2026 after 355 days
- Product code: SHH (Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P250008
Methodology: https://510kreport.com/methodology