# K062403: Imax Ceph Digital X-Ray Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Owandy
- Decided: Nov 14, 2006 after 89 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
No predicates in its family tree.
31 later devices descend from it; 1 cites it directly.
0 of 32 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
- K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 (2009), 30 descendants of its own
- K111152: Rotograph Evo 3D (2011), 27 descendants of its own
- K122981: Rayscan a-Expert 3D (2013), 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
The IMAX CEPH digital X-ray sensor is intended to capture extra oral x-ray images of a patient's head when exposed to X-rays for diagnostic purposes. The process is automatic and continues transmitting the digital image to a Personal Computer VIA USB interface.

Source page: https://510kreport.com/device/K062403
Methodology: https://510kreport.com/methodology