# K250947: VistaSoft 4.0 and VisionX 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Durr Dental SE
- Decided: Aug 27, 2025 after 152 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: 9 generations back to K930527 (1993). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213326: VisionX 3.0, Durr Dental SE (2021) Summary page 5.

## Most influential descendants
- K253930: Overjet Iris Intelligent Imaging System (2026), 0 descendants of its own

## Indications for use
VistaSoft 4.0 and VisionX 4.0 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 4.0 / VistaSoft 4.0 runs on user provided PC compatible computers and utilize previously cleared digital image capture devices for image acquisition. The software must only be used by authorized healthcare professionals in dental areas for the following tasks: - Filter optimization of the display of 2D and 3D images for improved diagnosis - Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitised 2D and 3D images and videos - Forwarding of images and additional data to external software (third-party software) The software is not intended for mammography use.

Source page: https://510kreport.com/device/K250947
Methodology: https://510kreport.com/methodology