# K030635: The Obsidian Pacs System

- Pathway: 510(k) (Traditional)
- Applicant: Obsidian Medical Technology, Inc.
- Decided: Mar 28, 2003 after 28 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: 4 generations back to K941322 (1995). 4 ancestors in all.
1 later device descends 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)
- K013088: Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech Easystress, Echotech 3D Imaging Systems, Inc. (2002)

## Most influential descendants
- K031567: 3D Invivo by Csist (2003), 0 descendants of its own

## Indications for use
The Obsidian PACS System is 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 but not limited to, radiologist, physicians, technicians, and nurses. The 3D Ultrasound Image Router is indicated for capture and storage of 2D images from an ultrasound system and reconstructing them into 3D ultrasound images. These images provide an approximate representation of the 3D volume for use in obstetric exams. The 3D images are not intended for use in diagnosis or quantitative measurements.

Source page: https://510kreport.com/device/K030635
Methodology: https://510kreport.com/methodology