# K140033: TARGET3D Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Convergent Life Sciences, Inc.
- Decided: Feb 27, 2014 after 51 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: 8 generations back to K930090 (1993). 88 ancestors in all.
No later device cites it as a predicate yet.
6 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120187: Multi-Modality Image Fusion, Igt, LLC Dba Eigen (2012) Summary page 1.
- K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option, Koelis (2013) Summary page 1.
- K041182: Syntegra, Adac Laboratories (2004) Summary page 1.

## Indications for use
target3D Fusion is a software application intended to be used by physicians in a clinic or hospital for visualization in 2D and 3D, registration, and fusion of Ultrasound (US), Magnetic Resonance (MR) and Computed Tomography (CT) images of the prostate. The software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ and regions of interest delineation, landmark selection, measurements, patient database management, and data reporting.

Source page: https://510kreport.com/device/K140033
Methodology: https://510kreport.com/methodology