# K192200: DynaCAD

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Oct 9, 2019 after 57 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: 1 generation back to K121517 (2012). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121517: Versavue Enterprise Suite, Icad, Inc. (2012) Summary page 5.

## Most influential descendants
- K202501: Quantib Prostate (2020), 3 descendants of its own
- K221106: Quantib Prostate (2022), 1 descendant of its own
- K233196: Medihub Prostate (2024), 0 descendants of its own
- K230772: Quantib Prostate (2023), 0 descendants of its own
- K212175: DynaCAD (2021), 0 descendants of its own

## Indications for use
DynaCAD The DynaCAD software consists of the MR Analysis Server software and the viewer workstation software. The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images. The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. DynaCAD software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates into the radiologist‘s existing departmental workflow and can be adapted to fit the needs of each user. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies. DynaLOC Breast The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device. DynaLOC Prostate DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices. The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/ or projected path of the interventional instrument. The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.

Source page: https://510kreport.com/device/K192200
Methodology: https://510kreport.com/methodology