# K113442: 3DI

- Pathway: 510(k) (Traditional)
- Applicant: Shina Systems, Ltd.
- Decided: Feb 16, 2012 after 87 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: 9 generations back to K930090 (1993). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112530: 3DI Including Cscore, Shina Systems, Ltd. (2011) Summary page 1.

## Indications for use
3Di is a software package of PACS workstation for handling multimodatity (CT, XA, MR, PET, SPECT, Ultrasound & Mammography) 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. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.

Source page: https://510kreport.com/device/K113442
Methodology: https://510kreport.com/methodology