# K093703: 3DI

- Pathway: 510(k) (Traditional)
- Applicant: Shina Systems, Ltd.
- Decided: Jan 19, 2010 after 49 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: 7 generations back to K930090 (1993). 26 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070226: Cardioct, Shina Systems, Ltd. (2007) Summary page 1.
- K082269: Visage Pacs, Version 6.0/CS 3.1, Visage Imaging, Inc. (2008) Summary page 1.
- K090462: Brilliance Dual Energy Option, Philips Medical Systems (Cleveland), Inc. (2009) Summary page 1.

## Most influential descendants
- K112530: 3DI Including Cscore (2011), 1 descendant of its own
- K113442: 3DI (2012), 0 descendants of its own

## Indications for use
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol' It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. SDi is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosisr by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This pr~oduct is not intended for use with or for diagnostic interpretation of Mammography images. The 3Diindications for use are processing of Cardiac CT angiography studies, including coronaries analysis, cardiac functional~assessment and CT colonoscopy.

Source page: https://510kreport.com/device/K093703
Methodology: https://510kreport.com/methodology