# K243234: Second Opinion® CS

- Pathway: 510(k) (Traditional)
- Applicant: Pearl, Inc.
- Decided: Jun 12, 2025 after 245 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P980025 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210365: Second Opinion, Pearl, Inc. (2022) Summary page 5.
- K222746: Overjet Caries Assist, Overjet, Inc. (2023) Summary page 6.

## Indications for use
Second Opinion® CS is a computer aided detection ("CADe”) software to aid in the detection and segmentation of caries in periapical radiographs. It is designed to aid dental health professionals to review periapical radiographs of permanent teeth in patients 12 years of age or older as a second reader.

Source page: https://510kreport.com/device/K243234
Methodology: https://510kreport.com/methodology