# K140445: Dexis Software: Dexis Imaging Suite, Dexis Mac

- Pathway: 510(k) (Special)
- Applicant: Imaging Sciences International, LLC
- Decided: Apr 23, 2014 after 61 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K162799: Cliniview (2017), 13 descendants of its own
- 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

## Indications for use
The DEXIS software is a software program for general dental and maxillofacial diagnostic imaging. It controls capture, display, enhancement and saving of X-ray digital images from digital imaging systems. It can also handle. other types of images acquired by digitizing film with a flat bed scanner, or valor images from intra-oral and extra-oral dental cameras.

Source page: https://510kreport.com/device/K140445
Methodology: https://510kreport.com/methodology