# K031779: Cadstream

- Pathway: 510(k) (Traditional)
- Applicant: Confirma, Inc.
- Decided: Aug 6, 2003 after 57 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 K954678 (1996). 11 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.
- K961023: Aidp (Accuimage Image Display Processor), Accuimage, Inc. (1996) Summary page 1.
- K020546: Fusion 7D, Mirada Solutions, Ltd. (2002)
- K984221: Functional Mri Package for Magetetom Vision MR, Siemens Corp. (1999) Summary page 1.

## Most influential descendants
- K041286: Dynacad V1.0 (2004), 17 descendants of its own
- K081556: Cadstream, Version 5.0 (2009), 9 descendants of its own
- K092954: Cadstream Version 5 (2009), 8 descendants of its own
- K170195: QuantX (2017), 4 descendants of its own
- K210670: BU-CAD (2021), 3 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 to minimize the impact of patient motion. segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. CADstream can also be used to provide accurate and reproducible measurements of the longest diameters and volume of segmented tissues. Patient management decisions should not be made based solely on the results of CADstrearn analysis.

Source page: https://510kreport.com/device/K031779
Methodology: https://510kreport.com/methodology