# K151137: X-View, Imagen

- Pathway: 510(k) (Abbreviated)
- Applicant: Edlen Imaging, LLC
- Decided: Jun 7, 2016 after 405 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K973642 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060328: Planmeca Promax 3D, Planmeca Oy (2006) Summary page 4.
- K150354: PAPAYA 3D Plus, Genoray Co., Ltd. (2015). Cleared while this submission was under review Summary page 4.

## Indications for use
The X-VIEW, IMAGEN, a panoramic x-ray imaging system with cephalometric capabilities, is an extraoral source x-ray system intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It has the capability of using cone beam volumetric technology techniques to generate dento-maxillofacial 3D images. The device uses a cone shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed via 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals.

Source page: https://510kreport.com/device/K151137
Methodology: https://510kreport.com/methodology