# K983283: Signet Dxis Direct X-Ray Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Signet Radiology, Inc.
- Decided: Nov 6, 1998 after 49 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
Longest line of descent: 1 generation back to K961826 (1996). 2 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961826: Digipan, Trophy Radiologie (1996) Summary page 1.
- K972312: Siemens Orthophos DS/DS Ceph, Siemens AG (1997) Summary page 1.
- (no number) Planmeca Dimax: named in the summary without a submission number

## Most influential descendants
- K041120: EV Apan Digital, Model K1VSM2000 (2004), 32 descendants of its own
- 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

## Indications for use
THE DXIS® IS INTENDED FOR DENTAL RADIOGRAPHIC EXAMINATION AND DIOGNOSIS OF DISEASES OF THE TEETH, JAW AND ORAL STRUCTURE.

Source page: https://510kreport.com/device/K983283
Methodology: https://510kreport.com/methodology