# K162799: Cliniview

- Pathway: 510(k) (Traditional)
- Applicant: Palodex Group OY
- Decided: Apr 25, 2017 after 202 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 K954678 (1996). 25 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141451: VixWin Platinum, Imaging Sciences International (Dba Gendex, LLC) (2014) Summary page 4.
- K140445: Dexis Software: Dexis Imaging Suite, Dexis Mac, Imaging Sciences International, LLC (2014) Summary page 4.
- K140713: Planmeca Romexis, Planmeca Oy (2014) Summary page 5.

## Most influential descendants
- K203156: DTX Studio Clinic (2020), 10 descendants of its own
- K213562: DTX Studio Clinic 3.0 (2022), 9 descendants of its own
- K233925: Relu Creator (2024), 6 descendants of its own
- K243989: Second Opinion® 3D (2025), 3 descendants of its own
- K260785: DS Core CBCT Anatomy (2026), 1 descendant of its own

## Indications for use
Cliniview software program is indicated for general dental and maxillofacial diagnostic imaging. It controls capture, 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/K162799
Methodology: https://510kreport.com/methodology