# K233925: Relu Creator

- Pathway: 510(k) (Traditional)
- Applicant: Relu BV
- Decided: Jun 13, 2024 after 183 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: 11 generations back to K954678 (1996). 28 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213562: DTX Studio Clinic 3.0, Nobel Biocare AB (2022) Summary page 4.

## Most influential descendants
- K243989: Second Opinion® 3D (2025), 3 descendants of its own
- 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
- K252538: CEPHX3D (2026), 0 descendants of its own

## Indications for use
Relu Creator is a software program for the management, transfer, and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

Source page: https://510kreport.com/device/K233925
Methodology: https://510kreport.com/methodology