# K130624: CONI

- Pathway: 510(k) (Traditional)
- Applicant: Globalmed
- Decided: May 7, 2013 after 60 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 K896095 (1990). 8 ancestors in all.
7 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)
- K081304: Alz Web Pacs, Version 1.0, Alz, Inc. (2008) Summary page 1.

## Most influential descendants
- K153653: DICOM Viewer (2016), 4 descendants of its own
- K191014: Elements Viewer (2020), 3 descendants of its own
- K232759: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (2024), 1 descendant of its own
- K132763: Advanced Viewer (2014), 1 descendant of its own
- K254265: Helion Viewer Suite (2026), 0 descendants of its own

## Indications for use
CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Single Frame Visible Light Photography (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection. CONi is not intended for use in mammography. CONi is not intended for diagnostic use on mobile devices

Source page: https://510kreport.com/device/K130624
Methodology: https://510kreport.com/methodology