# K060328: Planmeca Promax 3D

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Mar 15, 2006 after 34 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K973598 (1997). 5 ancestors in all.
61 later devices descend from it; 7 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052587: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf, J. Morita USA, Inc. (2005) Summary page 2.

## Most influential descendants
- K111152: Rotograph Evo 3D (2011), 27 descendants of its own
- K122981: Rayscan a-Expert 3D (2013), 24 descendants of its own
- K073350: Scanora 3D (2007), 24 descendants of its own
- K131695: Rayscan a-Expert 3D (2013), 23 descendants of its own
- K142247: Rayscan a-Expert 3D (2015), 22 descendants of its own

## Indications for use
Planmeca Promax 3D, is a three dimensional Cone Beam Computed Tomography (CBCT) x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K060328
Methodology: https://510kreport.com/methodology