# K012779: Iconnection 3D

- Pathway: 510(k) (Traditional)
- Applicant: Hinnovation, Inc.
- Decided: Nov 2, 2001 after 74 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: 3 generations back to K896095 (1990). 7 ancestors in all.
31 later devices descend from it; 1 cites 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)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.
- K982862: Radworks Medical Imaging Software with Quality Control Module, Applicare Medical Imaging, B.V. (1998) Summary page 1.
- K962699: Radworks Medical Imaging Software, Applicare Medical Imaging, B.V. (1996) Summary page 1.

## Most influential descendants
- K040876: Iconnection, Version 3.2.0.0 Medical Image Processing Software (2004), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K062154: Vital Connect 4.0 (2006), 12 descendants of its own
- K071362: Vital Connect 4.1 (2007), 11 descendants of its own
- K133993: Caas Workstation (2014), 10 descendants of its own

## Indications for use
iConnection 3D is a software application intended for integrated processing and distribution of 2D and 3D digitized data derived from CT and MRI (and others) scans for use by radiologists, clinicians, and other professionals to acquire, process, render, review, store, print, and distribute DICOM 3.0 compliant images utilizing standard PC hardware with MS 98, NT, or MS 2000 operating systems.

Source page: https://510kreport.com/device/K012779
Methodology: https://510kreport.com/methodology