# K250525: Second Opinion® Panoramic

- Pathway: 510(k) (Traditional)
- Applicant: Pearl, Inc.
- Decided: Nov 14, 2025 after 266 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: 10 generations back to K930527 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230144: Denti.AI Detect, Denti.Ai Technology, Inc. (2023) Summary page 5.
- K210365: Second Opinion, Pearl, Inc. (2022) Summary page 6.

## Indications for use
Second Opinion® Panoramic is a radiological automated image processing software device intended to identify and mark regions, in panoramic radiographs, in relation to suspected dental findings which include: Caries, Periapical radiolucency, and Impacted third molars. It is designed to aid dental health professionals to review panoramic radiographs of permanent teeth in patients 16 years of age or older as both a concurrent and second reader.

Source page: https://510kreport.com/device/K250525
Methodology: https://510kreport.com/methodology