# K051464: Planmeca Promax with Dec (Dynamic Exposure Control)

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Jun 24, 2005 after 21 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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: 1 generation back to K000163 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011619: Promax, Panoramic X-Ray Unit with Cephalostat, Planmeca Oy (2001) Summary page 2.
- K000163: PM 2002 Proline/Aec, Planmeca Oy (2000) Summary page 2.

## Most influential descendants
- K072244: Planmeca Proone (2007), 0 descendants of its own

## Indications for use
Planmeca Promax, panoramic x-ray imaging system with Cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device can be equipped with accessories to fulfil different diagnostic needs. In digital configuration the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.

Source page: https://510kreport.com/device/K051464
Methodology: https://510kreport.com/methodology