# K213326: VisionX 3.0

- Pathway: 510(k) (Special)
- Applicant: Durr Dental SE
- Decided: Nov 2, 2021 after 28 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: 8 generations back to K930527 (1993). 9 ancestors in all.
2 later devices descend 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)
- K192743: VisionX 2.4, Durr Dental SE (2019) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding image-generating systems. Image-generating systems that can be used with the software include optical video cameras, digital X-ray cameras, image plate scanners, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources. The software must only be used by authorized healthcare professionals in dental areas for the following tasks: - Filter optimisation 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/K213326
Methodology: https://510kreport.com/methodology