# K133030: Dynacad/Prostate Interventional (Dynaloc/Prostate)

- Pathway: 510(k) (Traditional)
- Applicant: Invivo Corporation
- Decided: Jan 22, 2014 after 118 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954678 (1996). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041286: Dynacad V1.0, Mri Devices Corp. (2004) Summary page 1.

## Most influential descendants
- K173312: ProBx Software (2018), 0 descendants of its own

## Recalls of this device
- Jan 24, 2018 · Class II · Z-1289-2018: Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. The defect causes the pharmacokinetic (PK) color maps to dis

## Indications for use
DynaCAD/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/K133030
Methodology: https://510kreport.com/methodology