# K230985: Planmeca Viso

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Dec 28, 2023 after 266 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K801623 (1980). 139 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181576: Planmeca Viso, Planmeca Oy (2018) Summary page 4.
- K160140: DENTRIa    series, Hdx Will Corp. (2016) Summary page 4.
- K223060: DigiX FDX, Allengers Medical Systems Limited (2022) Summary page 4.

## Most influential descendants
- K251842: Dental Computed Tomography X-ray System (2025), 1 descendant of its own
- K263033: Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) (2026), 0 descendants of its own
- K261748: Dental Cone-beam Computed Tomography (mDX-15P Series) (2026), 0 descendants of its own

## Indications for use
Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital X-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.

Source page: https://510kreport.com/device/K230985
Methodology: https://510kreport.com/methodology