# K103290: Edlen Imaging - Gemini Dusb

- Pathway: 510(k) (Abbreviated)
- Applicant: Edlen Imaging, LLC
- Decided: Sep 19, 2011 after 315 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: 3 generations back to K933455 (1994). 6 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072134: Schick Computed Oral Radiology System, Schick Technologies, Inc. (2007) Summary page 1.
- K070219: Suniray II Digital Radiography System, Suni Medical Imaging, Inc. (2007) Summary page 1.

## Most influential descendants
- K150823: EDLENi Intra-Oral Sensor (2015), 11 descendants of its own
- K151926: QuickRay HD Intraoral Sensor (2015), 10 descendants of its own
- K163282: Apex Dental Sensors (2017), 2 descendants of its own
- K162619: I View and Imagen Sensor (2016), 1 descendant of its own
- K230916: WeSensor (2023), 0 descendants of its own

## Indications for use
Edlen Imaging's Gemini DUSB3 sensor is a USB-driven digital X-ray sensor that acquires dental intra-oral X-ray images. The sensor will be operated by trained dental and related healthcare professionals to acquire dental intra-oral radiographs. The Gemini sensor can be used either in combination with special positioning devices, to facilitate alignment with the x-ray beam, or it may also be positioned manually.

Source page: https://510kreport.com/device/K103290
Methodology: https://510kreport.com/methodology