# K192165: Acteon Imaging Suite

- Pathway: 510(k) (Traditional)
- Applicant: De Gotzen S.R.L.
- Decided: Feb 11, 2020 after 186 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). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 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 5.
- K171385: Planmeca Romexis, Planmeca Oy (2017) Summary page 6.

## Indications for use
Acteon Imaging Suite software program is indicated for general dental and maxillofacial diagnostic imaging. It controls exam retrieval, display, enhancement, and saving of digital images from various digital imaging systems. It stores and communicates these images within the system or across computer systems at distributed locations.

Source page: https://510kreport.com/device/K192165
Methodology: https://510kreport.com/methodology