# K143318: DR Systems Zero Download 3D Viewer (Z3D)

- Pathway: 510(k) (Traditional)
- Applicant: Dr Systems, Inc.
- Decided: Mar 10, 2015 after 111 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060505 (2006). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060505: Voxar 3D Enterprise, Model 6.1, Barcoview Mis Edinburgh (2006) Summary page 4.

## Most influential descendants
- K182290: IBM iConnect Access (2018), 3 descendants of its own
- 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

## Recalls of this device
- Aug 14, 2017 · Class II · Z-3105-2017: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
- Aug 7, 2017 · Class II · Z-2566-2018: The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

## Indications for use
DR Systems Z3D is intended to provide reading physicians, referring physicians, and other appropriate healthcare professionals tools to aid in interpreting medical images, including: • Displaying DICOM compliant medical image volumes, such as CT, MRI, and PET. • Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images • 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. • Creating series of DICOM images and individually captured images that can be displayed and stored in a PACS. • 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.

Source page: https://510kreport.com/device/K143318
Methodology: https://510kreport.com/methodology