# K254096: VELMENI for DENTISTS (V4D) 3D

- Pathway: 510(k) (Traditional)
- Applicant: Velmeni, Inc.
- Decided: Jul 23, 2026 after 216 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: 13 generations back to K954678 (1996). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243989: Second Opinion® 3D, Pearl, Inc. (2025) Summary page 5.

## Indications for use
VELMENI for DENTISTS (V4D) 3D is radiological, automated, concurrent read, computer-assisted detection software intended to assist in the clinical detection of anatomical structures (maxilla plus cranium, mandible, mandibular canal, temporomandibular joint, maxillary sinus ,teeth ,airway) in CBCT radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for licensed dental professionals in examining radiographs of patients' teeth. The device is not intended as a substitute for a complete examination by the dental professional or their clinical judgment that considers other relevant information from the patient's history or actual in-vivo clinical assessment. Final diagnoses and patient treatment plan are the responsibility of the dental professional.

Source page: https://510kreport.com/device/K254096
Methodology: https://510kreport.com/methodology