# K212175: DynaCAD

- Pathway: 510(k) (Abbreviated)
- Applicant: Invivo Corporation
- Decided: Aug 2, 2021 after 21 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: 2 generations back to K121517 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192200: DynaCAD, Invivo Corporation (2019) Summary page 4.

## Indications for use
DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: • MR Analysis Server post-processing software application facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. • Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server. • Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation. DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue.

Source page: https://510kreport.com/device/K212175
Methodology: https://510kreport.com/methodology