# K243893: Second Opinion® Pediatric

- Pathway: 510(k) (Traditional)
- Applicant: Pearl, Inc.
- Decided: May 5, 2025 after 138 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: 2 generations back to P980025 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
Second Opinion® Pediatric is a computer aided detection ("CADe”) software to aid in the detection of caries in bitewing and periapical radiographs. The intended patient population of the device is patients aged 4 years and older that have primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs.

Source page: https://510kreport.com/device/K243893
Methodology: https://510kreport.com/methodology