# K150823: EDLENi Intra-Oral Sensor

- Pathway: 510(k) (Abbreviated)
- Applicant: Edlen Imaging, LLC
- Decided: Aug 26, 2015 after 152 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: 4 generations back to K933455 (1994). 7 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103290: Edlen Imaging - Gemini Dusb, Edlen Imaging, LLC (2011) Summary page 4.
- K072134: Schick Computed Oral Radiology System, Schick Technologies, Inc. (2007) Summary page 4.

## Most influential descendants
- 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
- K202369: RXS 1000 (2021), 0 descendants of its own

## Indications for use
The EDLENI sensor is an intra-oral x-ray sensor driven via CMOS technology indicated for the acquirement of intra-oral dental radiographs and intended for dental patients. The EDLENi will be handled via qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The sensors will be used to provide intra-oral radiographic images that ultimately diagnose general dental complications or abnormalities. The EDLENi sensor can be used in combination with positioning devices to facilitate alignment with the x-ray beam, or it may be positioned manually.

Source page: https://510kreport.com/device/K150823
Methodology: https://510kreport.com/methodology