# K090223: Icad Breast Interventional Planning Software, Model D70024

- Pathway: 510(k) (Traditional)
- Applicant: Icad, Inc.
- Decided: Mar 31, 2009 after 60 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). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043216: Cadstream Version 4.0, Confirma, Inc. (2005) Summary page 2.
- K041286: Dynacad V1.0, Mri Devices Corp. (2004) Summary page 2.
- K020289: Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias, Machnet BV (2002) Summary page 2.

## Recalls of this device
- Jan 21, 2015 · Class II · Z-1243-2015: A device malfunction may cause the biopsy needle to fail to reach the intended target. If location confirming radiographs are not taken and properly evaluated, biopsy site mislocation can result in no

## Indications for use
The iCAD Breast Interventional Planning Software supports the use of interventional breast coils and MR stereotactic localization devices to perform magnetic resonance (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.

Source page: https://510kreport.com/device/K090223
Methodology: https://510kreport.com/methodology