# K092954: Cadstream Version 5

- Pathway: 510(k) (Special)
- Applicant: Confirma, Inc.
- Decided: Nov 6, 2009 after 42 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913770 (1991). 74 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081556: Cadstream, Version 5.0, Confirma, Inc. (2009) Summary page 1.
- K053301: Cedara I-Response Cedara Pet/CT, Cedara Software Corp. (2006) Summary page 1.
- K081512: Stealthviz Advanced Planning Application with Stealthdti Package, Medtronic Navigation, Inc. (2008) Summary page 1.

## Most influential descendants
- K170195: QuantX (2017), 4 descendants of its own
- K210670: BU-CAD (2021), 3 descendants of its own
- K231130: TumorSight Viz (2023), 2 descendants of its own
- K243189: TumorSight Viz (2024), 1 descendant of its own
- K260086: CadAI-B Dx (2026), 0 descendants of its own

## Recalls of this device
- Jan 30, 2016 · Class II · Z-0137-2017: The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may result in in
- Nov 1, 2012 · Class II · Z-2871-2016: An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.
- Oct 19, 2011 · Class II · Z-0118-2017: Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.

## Indications for use
CADstream is intended to be used in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream supports evaluation of dynamic MR data acquired during contrast administration. CADstream performs other user selected processing functions (such as image registration, subtractions, measurements, 3D renderings, and reformats). CADstream also includes user-configurable features for reporting on findings in breast or general MRI studies. Additionally, CADstream assists users in planning MIM guided interventional procedures. When interpreted by a skilled physician, this device provides information that may be used for screening, diagnosis, and interventional planning. Patient management decisions should not be made based solely on the results of CADstream. CADstream may also be used as an image viewer of multi-modality, digital images, including ultrasound and mammography. CADstream is not intended for primary interpretation of digital mammography images.

Source page: https://510kreport.com/device/K092954
Methodology: https://510kreport.com/methodology