# K043216: Cadstream Version 4.0

- Pathway: 510(k) (Traditional)
- Applicant: Confirma, Inc.
- Decided: Jan 6, 2005 after 45 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: 4 generations back to K913770 (1991). 7 ancestors in all.
263 later devices descend from it; 9 cite it directly.
0 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033400: Seno Advantage, Ge Medical Systems W-400 (2003) Summary page 1.
- K033712: Modification to Sectra IDS5 Radiology Workstation - Version 10.1, Sectra-Imtec AB (2003) Summary page 1.
- K040376: Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package, Sectra-Imtec AB (2004) Summary page 1.

## Most influential descendants
- K050846: B-Cad System, Version 1.0 (2005), 123 descendants of its own
- K141620: RS80A Diagnostic Ultrasound System (2014), 101 descendants of its own
- K143089: WS80A Diagnostic Ultrasound System (2014), 99 descendants of its own
- K143264: H60 V2.00 Diagnostic Ultrasound System (2014), 98 descendants of its own
- K150478: A35 Diagnostic Ultrasound System (2015), 97 descendants of its own

## Indications for use
CADstream 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 provides quantitative measurements of morphological features of the segmented tissues. CADstream performs other user-defined post-processing functions (image subtractions, multiplanar and oblique reformats, maximum intensity projections, image averaging, removal of cardiac artifact). CADstream also can be used to provide accurate and reproducible measurements of the segmented tissues volumes (volumes of interest (VOI)). These measurements include longest diameter, longest in-plane diameters, volume measurement (reported in cc), ratio of breast volume to V0l, distance of VOl to anatomical landmarks, and 3D renderings of the VOl. The system includes an optional remote image viewer (CADalystTM), optimized for viewing breast MR studies processed by CADstream. CADalyst also displays and telecommunicates images from a number of other medical modalities, including ultrasound and digitized mammographic images, processed data from FDA-cleared third party image processing systems, and FDA-approved systems for computer-aided detection and advanced image processing. The ultrasound and digitized mammographic images displayed on the CADalyst remote image viewer must not be used for primary diagnostic interpretation. CADstreamTM includes software to support the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures (SureLoc TM). 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. CADstream also includes the option to add annotations based on the American College of Radiology's Breast Imaging Reporting and Data System (B1-RADS®) Breast Imaging Atlas. 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/K043216
Methodology: https://510kreport.com/methodology