# K111103: Digital X-Ray Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Rf Co., Ltd.
- Decided: Jan 5, 2012 after 260 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: 2 generations back to K961826 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062376: Direct Digital Radiography CCD Imaging Sensor, Naomi, Rf Systems Lab. (2006) Summary page 1.
- K982661: CDR - Pan  Model 4700, Schick Technologies, Inc. (1998) Summary page 1.
- K983283: Signet Dxis Direct X-Ray Imaging System, Signet Radiology, Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K012514: Digipan / Dpi, Trophy Radiologie (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The NAOMI-DPX D100 is indicated for use in acquiring Panoramic radiographic images at the dento-maxillofacial region. The image generated is displayed on a computer monitor. It is intended to replace radiographic film/screen system in dental diagnostic procedures

Source page: https://510kreport.com/device/K111103
Methodology: https://510kreport.com/methodology