# K021718: Intraoral Imaging System, Model Suni-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Suni Imaging Microsystems, Inc.
- Decided: Aug 15, 2002 after 84 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.
38 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070219: Suniray II Digital Radiography System (2007), 35 descendants of its own
- 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

## Indications for use
The Suni Digital Radiography System is used to collect dental x-rays 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/K021718
Methodology: https://510kreport.com/methodology