# K050846: B-Cad System, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: The Medipattern Corporation
- Decided: May 26, 2005 after 52 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: 5 generations back to K913770 (1991). 11 ancestors in all.
123 later devices descend from it; 5 cite it directly.
0 of 135 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 1.
- K021966: Q Lab Software, Advanced Technology Laboratories, Inc. (2002) Summary page 1.
- K023877: Q Lab Quantification Software with Strain Rate Quantification Plug-in, Philips Ultrasound, Inc. (2002) Summary page 1.
- K040227: Qlab Quantification Software, Philips Ultrasound (2004) Summary page 1.

## Most influential descendants
- 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
- K151663: RS80A Diagnostic Ultrasound System (2015), 96 descendants of its own

## Indications for use
B-CAD is a computer-aided detection (CAD) software application designed to assist radiologists to analyze breast ultrasound images. B-CAD automatically segments and classifies shape and orientation characteristics of user-selected regions of interest (ROI). The software allows the user to annotate, tag, measure, and automatically record selected views. The software automatically generates reports from user inputs annotated during the image analysis process. An output may be viewed and sent to standard film or paper printers or sent electronically to an intranet web server or other DICOM device. The software may retrieve archived reports from a web server or other DICOM device. B-CAD includes the option to add annotations based on the ACR-BI-RADS® Breast Imaging Atlas. In addition, the report form has been designed to support compliance with the ACR-BI-RADS® Ultrasound Lexicon Classification Form. 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 solely on the results of B-CAD analysis. The ultrasound images displayed on B-CAD must not be used for primary diagnostic interpretation.

Source page: https://510kreport.com/device/K050846
Methodology: https://510kreport.com/methodology