# K151438: Dentrix Ascend Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Realcloud Imaging, Inc.
- Decided: Jul 7, 2015 after 39 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K913770 (1991). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112974: Picture Archiving and Communications System, Curve Dental, Inc. (2011) Summary page 4.

## Indications for use
Dentrix Ascend Imaging is a web-based Dental Picture Archiving and Communications Systems (PACS), i.e. dental imaging software, that enables dental care facilities to acquire, process, edit, and enhance dental images. Dentrix Ascend Imaging provides a web-based interface for image acquisition and management of images which are used in the field of Dentistry and when operated by dental professionals who are responsible for providing dental care. Images can be acquired from dental image acquisition devices and/or consumer imaging devices such as color digital cameras. Previously acquired images or volumes can be selected for upload directly from the user's computer. Supported images include intraoral and extraoral dental x-rays/volumes and intraoral and extraoral color images produced by intraoral video or consumer digital cameras. Dentrix Ascend Imaging is used for diagnostic purposes in the field of dentistry. Dentrix Ascend Imaging is not intended for diagnostic use on a mobile display. Images can be edited/enhanced (e.g. zoomed, contrast adjusted, inverted, annotated, rotated, filtered, etc...) as well as exported to standard image file formats.

Source page: https://510kreport.com/device/K151438
Methodology: https://510kreport.com/methodology