# K122205: EXINI

- Pathway: 510(k) (Traditional)
- Applicant: Exini Diagnostics AB
- Decided: Aug 15, 2012 after 21 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: 7 generations back to K950279 (1995). 38 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111319: Ibis Explorer and Markup Software, Medqia (2011) Summary page 1.

## Most influential descendants
- K191262: aBSI (2019), 2 descendants of its own
- K211655: aPROMISE (2021), 1 descendant of its own
- K173444: Quantitative Total Extensible Imaging (QTxI) (2018), 1 descendant of its own
- K233998: TRAQinform IQ (2024), 0 descendants of its own
- K220590: aPROMISE X (2022), 0 descendants of its own

## Indications for use
EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NMV) and computed tomography (aT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.

Source page: https://510kreport.com/device/K122205
Methodology: https://510kreport.com/methodology