# K031567: 3D Invivo by Csist

- Pathway: 510(k) (Traditional)
- Applicant: Chung-Shan Institute of Science and Technology
- Decided: Oct 2, 2003 after 136 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 K941322 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030635: The Obsidian Pacs System, Obsidian Medical Technology, Inc. (2003)

## Indications for use
3D inVIVO is a PACS System used to acquire, transmit, view, and store image or patient data. This data can be transmitted, stored, and viewed over a computer network or off-site using an Internet connection. The typical users of this system are trained professionals including radiologist, physicians, technicians, and nurses. The 3D inVIVO is indicated for capture and storage of 2D images from ultrasound systems and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume and are not intended for use in diagnosis or quantitative measurements.

Source page: https://510kreport.com/device/K031567
Methodology: https://510kreport.com/methodology