# K253930: Overjet Iris Intelligent Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Overjet, Inc.
- Decided: Apr 10, 2026 after 122 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 10 generations back to K930527 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250947: VistaSoft 4.0 and VisionX 4.0, Durr Dental SE (2025) Summary page 6.

## Indications for use
Overjet Iris Intelligent Imaging System is a web-based dental image management software (Picture Archiving and Communication System, PACS). The system enables acquisition, cloud-based storage, archival, display, and distribution of digital dental images. Images can be acquired from dental image acquisition devices (intraoral sensors or extraoral panoramic machines) and/or consumer imaging devices such as color digital cameras. In addition, the system provides automated identification and reporting of image capture quality issues, including the presence of intraoperative tools within the field of view, cone cut, overlapping interproximal contacts, inadequate crestal bone coverage, inadequate apical coverage, inadequate coronal coverage, foreshortening, and elongation. These image quality indicators are intended to assist clinicians in evaluating the adequacy of intraoral radiographs but are not a substitute for professional clinical judgment. The device is intended to provide images for review and diagnostic use by trained dental professionals

Source page: https://510kreport.com/device/K253930
Methodology: https://510kreport.com/methodology