# K043307: Cranex D

- Pathway: 510(k) (Traditional)
- Applicant: Soredex Palodex Group OY
- Decided: Dec 17, 2004 after 16 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: 2 generations back to K972312 (1997). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972312: Siemens Orthophos DS/DS Ceph, Siemens AG (1997) Summary page 1.
- K040382: Cranex Basex D or Cranex Excel D, Soredex Palodex Group OY (2004) Summary page 1.

## Most influential descendants
- K110371: Encompass HF100- Eagle Panoramic/Cephalometric X-Ray (2011), 1 descendant of its own
- K063459: Cranex Novus (2006), 1 descendant of its own
- K141130: Encompass (2014), 0 descendants of its own
- K092591: Orthopantomograph OP30 (2009), 0 descendants of its own

## Indications for use
The Cranex D dental panoramic equipment is indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures. The Cranex D is upgradeable for cephalometric radiography and examinations related thereto.

Source page: https://510kreport.com/device/K043307
Methodology: https://510kreport.com/methodology