# K182290: IBM iConnect Access

- Pathway: 510(k) (Traditional)
- Applicant: Merge Healthcare Incorporated
- Decided: Sep 25, 2018 after 33 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: 5 generations back to K904519 (1991). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092915: Cedara Webaccess, Model: 2.4, Cedara Software Corp. (2010) Summary page 4.
- K143318: DR Systems Zero Download 3D Viewer (Z3D), Dr Systems, Inc. (2015) Summary page 4.

## Most influential descendants
- K203104: IBM iConnect Access (2021), 2 descendants of its own
- K254237: Cci Pacs Viewer (Pacs-US-001) (2026), 0 descendants of its own
- K250301: Merge Universal Viewer (MUV) (2025), 0 descendants of its own

## Indications for use
The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including: o Displaying DICOM compliant medical images and non-DICOM content using XDS o Reformatting images, including creation of MPRs, MIPS, MinlPs, color/monochrome 3D volume rendered images o Manipulating displayed images via control of slice thickness, slice interval, obliquity, perspective, rotation, window/level, crop, zoom, color/monochrome transformations, segmentation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. o Creating individually captured DICOM images that can be displayed and stored in a PACS 0 Measuring coronary calcium, which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms. The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.

Source page: https://510kreport.com/device/K182290
Methodology: https://510kreport.com/methodology