# K112974: Picture Archiving and Communications System

- Pathway: 510(k) (Traditional)
- Applicant: Curve Dental, Inc.
- Decided: Oct 20, 2011 after 15 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: 6 generations back to K913770 (1991). 12 ancestors in all.
7 later devices descend from it; 4 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)
- K982422: Eaglesoft Chairside, Eaglesoft, A Patterson Co. (1998) Summary page 1.
- K083018: Centricity Pacs Web Diagnostic, Ge Healthcare Dynamic Imaging Solutions (2008) Summary page 2.

## Most influential descendants
- K132342: XVWEB (2013), 3 descendants of its own
- K210682: SOTA Cloud Imaging (2021), 1 descendant of its own
- K253111: Aeka Imaging (2026), 0 descendants of its own
- K251880: Archy Dental Imaging (2025), 0 descendants of its own
- K220684: Oryx Cloud Imaging (2022), 0 descendants of its own

## Indications for use
CURVE IMAGE is an internet-based, image management software (PACS) that enables dental offices to keep records of hard and soft tissue charts in a form of digital images. The system uses a Web-based interface and includes acquisition, editing and storage of digital images. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Images can be acquired from standard dental imaging devices, or can be uploaded directly from the user's computer. Images can be edited (e.g., zoomed, contrast, rotated, etc.), as well as exported. The system is designed to provide images for diagnostic use.

Source page: https://510kreport.com/device/K112974
Methodology: https://510kreport.com/methodology