# K011619: Promax, Panoramic X-Ray Unit with Cephalostat

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Jun 29, 2001 after 35 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122643: Vantage Model V5000, V5100, V5000C, V5100C (2013), 1 descendant of its own
- K051464: Planmeca Promax with Dec (Dynamic Exposure Control) (2005), 1 descendant of its own
- K201667: Midmark Extraoral Imaging System (EOIS) (2020), 0 descendants of its own
- K091866: Progeny Vantage Panoramic X-Ray System (2009), 0 descendants of its own
- K072244: Planmeca Proone (2007), 0 descendants of its own

## Indications for use
The 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 discases 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/K011619
Methodology: https://510kreport.com/methodology