# K081093: 3-D Imaging Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Eigen, LLC
- Decided: May 1, 2008 after 14 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 K954678 (1996). 9 ancestors in all.
31 later devices descend from it; 9 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063107: 3DNET Suite, Biotronics3D, Ltd. (2006) Summary page 1.
- K051673: Xeleris 2 Processing and Review Workstation, GE Medical Systems (2005) Summary page 1.

## Most influential descendants
- K153073: UroNav (Version 2.0) (2015), 11 descendants of its own
- K093672: Aegis Navigation Anda Egis Pelvic Application (2009), 8 descendants of its own
- K100793: Urostation 3D Prostate Suite (2010), 7 descendants of its own
- K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option (2013), 6 descendants of its own
- K120187: Multi-Modality Image Fusion (2012), 4 descendants of its own

## Indications for use
The 3-D Imaging Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.

Source page: https://510kreport.com/device/K081093
Methodology: https://510kreport.com/methodology