# K160506: Planmeca ProMax 3D Max, Planmeca Maximity

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: May 20, 2016 after 86 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: 5 generations back to K973598 (1997). 8 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093590: Planmeca Promax 3D Max, Planmeca Oy (2010) Summary page 5.
- K103659: CS 9300, CS 9300C, Trophy (2011) Summary page 5.

## Most influential descendants
- K181576: Planmeca Viso (2018), 4 descendants of its own
- K230985: Planmeca Viso (2023), 3 descendants of its own
- K251842: Dental Computed Tomography X-ray System (2025), 1 descendant of its own
- K181136: CS 9600 (2018), 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

## Indications for use
The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital X-ray 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/K160506
Methodology: https://510kreport.com/methodology