# K081262: DC Neuro

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Jun 17, 2008 after 43 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 K913475 (1991). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052078: Achieva, Intera and Panorama 1.0 Release 2-Series, Philips Medical Systems Nederland B.V. (2005) Summary page 1.
- K990329: Philips Easyvision Workstation, Philips Medical Systems North America, Inc. (1999) Summary page 1.
- K971965: Philips Easyvision, Philips Medical Systems, Inc. (1998) Summary page 1.
- K953095: Philips Easyvision, Philips Medical Systems, Inc. (1995) Summary page 1.
- K032096: Philips Viewforum 2003, Philips Medical Systems (2003) Summary page 1.

## Most influential descendants
- K113701: Visia Neuro (2012), 1 descendant of its own
- K141514: Synapse 3D Tensor Analysis (2014), 0 descendants of its own

## Indications for use
DC Neuro is an image processing software package designed to run on standard PC hardware (workstation). The required workstation hardware consists of standard, "off-the-shelf" computer components. DC Neuro software receives image data from medical imaging devices such as Magnetic Resonance Imaging systems or from image archives, PACS. DC Neuro can be used to perform image viewing, image manipulation, image quantification, communication, and printing. DC Neuro provides both analysis and viewing capabilities which integrate both anatomical and physiologic/functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic analysis, and vessel analysis in both 2D and/or 3D views. BOLD fMRI: The BOLD analysis is useful in quantifying small susceptibility changes in the human brain, created by the execution of a specific task. Diffusion/Fiber tracking: The diffusion of water molecules through brain tissue can be measured with diffusion-weighted MRI scanning. Actual diffusion properties depend on the local tissue. With fiber tracking, the directional dependency can be used to visualize the white matter structure in the brain. Dynamic Analysis: Dynamic analysis is intended for visualization and analysis of MR dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary. Vessel Analysis: Allows the visualization of vascular morphology from MR images. 3D Visualization: 3D rendering allows the visualization of bone, vascular structures, and selected anatomy as three dimensional object surfaces projected on a flat screen.

Source page: https://510kreport.com/device/K081262
Methodology: https://510kreport.com/methodology