# K041020: Cadstream Version 3.1

- Pathway: 510(k) (Traditional)
- Applicant: Confirma, Inc.
- Decided: Jul 7, 2004 after 78 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031779: Cadstream, Confirma, Inc. (2003) Summary page 1.
- K020289: Mics Intervention Aid, Catalog # Mics-Mia and Mics-Mias, Machnet BV (2002) Summary page 1.
- K000832: Sterotactic Localization Device (SLD), Philips Medical Systems North America, Inc. (2000) Summary page 1.
- K010773: Breast Biopsy Device/Magnetom Systems, Siemens Medical Solutions USA, Inc. (2001) Summary page 1.

## Indications for use
CADstreamTM is a Computer Aided Detection (CAD) system intended for use in analyzing magnetic resonance imaging (MRI) studies. CADstream automatically registers serial patient image acquisitions (in 2D or 3D) to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps, referred to as angiogenesis maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). CADstream also can be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues, including automated determination of volumes of interest (VOI), calculation of the longest diameter in X, Y and Z dimensions, the areas of VOI, the volume measurements of VOI (reported in cc), and 3D renderings of VOI. The system includes an optional remote image viewer (CADalystTM), optimized for viewing breast MR studies processed by CADstream. CADstreamTM includes software to support the use of breast interventional coils and MR stereotactic localization devices to perform breast interventional procedures (SureLocTM). 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. When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CADstream analysis.

Source page: https://510kreport.com/device/K041020
Methodology: https://510kreport.com/methodology