# K111319: Ibis Explorer and Markup Software

- Pathway: 510(k) (Traditional)
- Applicant: Medqia
- Decided: Aug 5, 2011 after 87 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: 6 generations back to K950279 (1995). 37 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K053133: Syngo Dynamics, Version 5.0, Siemens Medical Solutions USA, Inc. (2005) Summary page 1.
- K082269: Visage Pacs, Version 6.0/CS 3.1, Visage Imaging, Inc. (2008) Summary page 1.

## Most influential descendants
- K122205: EXINI (2012), 5 descendants of its own
- 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

## Indications for use
IBIS Explorer and Markup Software is a Picture Archiving and Communication System (RAGS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Besides general image interpretation and processing tools, IBIS provides specific tool sets for several clinical applications, including: * Oncology, including lesion marking and analysis * Anatomic structure marking, volume measurement and analysis Only DIGOM for presentation images can be used on an FDA approved monitor for mammography for image diagnosis. Only uncompressed or non-lossy compressed images must be used for image diagnosis in mammography.

Source page: https://510kreport.com/device/K111319
Methodology: https://510kreport.com/methodology