# K243989: Second Opinion® 3D

- Pathway: 510(k) (Traditional)
- Applicant: Pearl, Inc.
- Decided: May 23, 2025 after 148 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: 12 generations back to K954678 (1996). 29 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233925: Relu Creator, Relu BV (2024) Summary page 5.

## Most influential descendants
- K260785: DS Core CBCT Anatomy (2026), 1 descendant of its own
- K262127: DS Core CBCT Anatomy (2026), 0 descendants of its own
- K254096: VELMENI for DENTISTS (V4D) 3D (2026), 0 descendants of its own

## Indications for use
Second Opinion® 3D is a radiological automated image processing software device intended to identify and mark clinically relevant anatomy in dental CBCT radiographs; specifically Dentition, Maxilla, Mandible, Inferior Alveolar Canal and Mental Foramen (IAN), Maxillary Sinus, Nasal space, and airway. 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 health professionals to review CBCT radiographs of patients 12 years of age or older as a concurrent and second reader

Source page: https://510kreport.com/device/K243989
Methodology: https://510kreport.com/methodology