# K041286: Dynacad V1.0

- Pathway: 510(k) (Traditional)
- Applicant: Mri Devices Corp.
- Decided: Jul 21, 2004 after 69 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954678 (1996). 23 ancestors in all.
17 later devices descend from it; 6 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)
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000) Summary page 1.
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.
- K961023: Aidp (Accuimage Image Display Processor), Accuimage, Inc. (1996) Summary page 1.
- K020546: Fusion 7D, Mirada Solutions, Ltd. (2002) Summary page 1.
- K984221: Functional Mri Package for Magetetom Vision MR, Siemens Corp. (1999) Summary page 1.
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 1.
- K971965: Philips Easyvision, Philips Medical Systems, Inc. (1998) Summary page 1.
- K013574: Accent, Confirma, Inc. (2002) Summary page 1.
- K031779: Cadstream, Confirma, Inc. (2003) Summary page 1.
- K031350: 3TP Software Option, 3tp, LLC (2003) Summary page 1.
- K032576: Biopsy Breast Coil, Model BBC, Mri Devices Corp. (2003) Summary page 1.
- K010570: Breast Immobiization and Biopsy Device MR-Biopsy 160, Mri Devices Corp. (2001) Summary page 1.

## Most influential descendants
- K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K170195: QuantX (2017), 4 descendants of its own
- K210670: BU-CAD (2021), 3 descendants of its own
- K231130: TumorSight Viz (2023), 2 descendants of its own

## Indications for use
DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions such as image subtractions, multiplanar reformats, and maximum intensity projections. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. DynaCAD is designed to provide a reliable means of visualizing the presence and pattern of contrast induced enhancements of MR data sets. In addition to being a Computer Aided Detection (CAD) system, DynaCAD also provides an intervention planning tool, which assists with MRI guidance of percutaneous interventional procedures. When interpreted by a skilled physician, this device provides information that may be useful in screening, diagnosis, intervention planning and monitoring. DynaCAD can also be used to provide accurate measurements of the diameters, areas, volumes and uptake characteristics of segmented tissues in any original, registered, analyzed or reformatted image. Patient management decisions should not be made based solely on the results of DynaCAD analysis.

Source page: https://510kreport.com/device/K041286
Methodology: https://510kreport.com/methodology