# K190629: DBSWIN and VISTAEASY Imaging Software

- Pathway: 510(k) (Traditional)
- Applicant: Durr Dental SE
- Decided: Apr 1, 2019 after 20 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 K930527 (1993). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161444: DBSWIN and VistaEasy Imaging Software, Duerr Dental AG (2016) Summary page 5.

## Most influential descendants
- K192743: VisionX 2.4 (2019), 3 descendants of its own
- K213326: VisionX 3.0 (2021), 2 descendants of its own
- K250947: VistaSoft 4.0 and VisionX 4.0 (2025), 1 descendant of its own
- K253930: Overjet Iris Intelligent Imaging System (2026), 0 descendants of its own
- K203287: Dbswin, Vistaeasy (2020), 0 descendants of its own

## Indications for use
DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience. DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by DÜRR Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing. DBSWIN and VistaEasy software are not intended for mammography use.

Source page: https://510kreport.com/device/K190629
Methodology: https://510kreport.com/methodology