# K063107: 3DNET Suite

- Pathway: 510(k) (Traditional)
- Applicant: Biotronics3D, Ltd.
- Decided: Oct 27, 2006 after 16 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: 3 generations back to K954678 (1996). 5 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963697: Advanced Diagnostic Viewer (Adv), Bio-Vascular, Inc. (1996) Summary page 1.
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.

## Most influential descendants
- K081093: 3-D Imaging Workstation (2008), 31 descendants of its own
- 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

## Indications for use
The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans. The 3Dnet Suite provides several levels of functionality to the user: - basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvglP, MIP, MinIP, measurements, annotations, reporting, distribution etc. - tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, grayscale VR slab, 3D volume review, path definition and boundary detection etc. - Specialist tools and workflow enhancements for specific clinical applications which provide target workflows, custom UI, measurement and visualization, including colon screening which is indented for the reviewing of patients for colonic polyps, tumors and other lesions using tomographic colonography.

Source page: https://510kreport.com/device/K063107
Methodology: https://510kreport.com/methodology