# K974877: Cranex Tome Ceph, or Cranex Tome

- Pathway: 510(k) (Traditional)
- Applicant: Orion Corporation Soredex
- Decided: Mar 27, 1998 after 88 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K880982 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884650: Resubmitted Scanora, Orion Corp. (1989) Summary page 1.
- K880982: Oralix Pan DC Iii Ceph or Panoramic Mode Only, Orion Corporation Soredex (1988) Summary page 1.

## Recalls of this device
- Apr 28, 2006 · Not classified · Z-0816-2007: There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.

## Indications for use
Tomographic X-ray System, which is intended for diagnostic dental radiography at the dento-maxillofacial region and additionally cephalometry. The imaging methods are narrow beam radiography and spiral tomography and central projection cephalometry. The method of image reception is film / intensifying screens.

Source page: https://510kreport.com/device/K974877
Methodology: https://510kreport.com/methodology