# K070219: Suniray II Digital Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Suni Medical Imaging, Inc.
- Decided: Feb 7, 2007 after 15 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 K021718 (2002). 1 ancestor in all.
35 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021718: Intraoral Imaging System, Model Suni-Ray, Suni Imaging Microsystems, Inc. (2002) Summary page 1.

## Most influential descendants
- K090458: Dexis Sensor (2009), 18 descendants of its own
- K103290: Edlen Imaging - Gemini Dusb (2011), 13 descendants of its own
- K150823: EDLENi Intra-Oral Sensor (2015), 11 descendants of its own
- K151926: QuickRay HD Intraoral Sensor (2015), 10 descendants of its own
- K210312: PlutoX Digital Intraoral X-Ray Imaging System (2021), 5 descendants of its own

## Indications for use
The SuniRay II Digital Radiography System is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

Source page: https://510kreport.com/device/K070219
Methodology: https://510kreport.com/methodology