# K172224: DTX Studio diagnose

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare AB
- Decided: Jan 11, 2018 after 170 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: 9 generations back to K954678 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162799: Cliniview, Palodex Group OY (2017) Summary page 4.

## Indications for use
DTX Studio diagnose is a software program for the transfer and visualization of dental and craniomaxillofacial image information. It displays and enhances digital images from various sources to support the diagnostic process. It stores and communicates these images within the system or across computer systems at distributed locations.

Source page: https://510kreport.com/device/K172224
Methodology: https://510kreport.com/methodology