# K072665: Suniray 5.2

- Pathway: 510(k) (Traditional)
- Applicant: Orangedental GmbH & Co. KG
- Decided: Oct 3, 2007 after 12 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: 3 generations back to K930527 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983111: Xray Vision, Apteryx, Inc. (1998)

## Indications for use
Uses for SuniRay in the dental industry are as follows: Organize and archive radiographs and patient related files Facilitate sharing and transmission of information between doctors, other applications and other computers Place markers and annotations on radiographs for diagnostic purposes Allows users to dimension radiographs based on dimensions of X-ray sensors or reference objects. Provides image-processing tools such as sharpening, colorizing, resizing, etc. (none of which physically alter images). Permits sending of data by email. The target group for using SuniRay for diagnostic purposes will be the doctor/dentist population. This software is primarily used to store a patient's imaging data (i.e. radiographs) in a form compatible with today's networked online medical practice management software. This software may also be used to transmit radiographs to specialists who will be treating the patient or the insurance company for approval of procedure and etc.

Source page: https://510kreport.com/device/K072665
Methodology: https://510kreport.com/methodology