# K243230: Second Opinion® BLE

- Pathway: 510(k) (Traditional)
- Applicant: Pearl, Inc.
- Decided: May 9, 2025 after 213 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K930527 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210187: Overjet Dental Assist, Overjet, Inc. (2021) Summary page 5.

## Indications for use
Second Opinion® BLE is a radiological automated image processing software device intended to identify and display bone level measurements in bitewing and periapical radiographs. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older as a concurrent and second reader.

Source page: https://510kreport.com/device/K243230
Methodology: https://510kreport.com/methodology