# K072258: BI-Rads Companion

- Pathway: 510(k) (Traditional)
- Applicant: Almen Laboratories, Inc.
- Decided: May 16, 2008 after 276 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: 6 generations back to K913770 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050846: B-Cad System, Version 1.0, The Medipattern Corporation (2005) Summary page 1.

## Indications for use
BI-RADS Companion TM ("BRC") is a computer-aided image viewing and report generating tool designed to assist radiologists in the analysis of ultrasound images of breast masses by making the ACR "BI-RADS Classification Form and Lexicon®" ("ABCFL") available in electronic format. The user can view any selected image from a case and segment the lesion from the background by applying a user selected threshold or outlining the lesion manually with a cursor. The user can annotate, tag, measure, and record selected views. Under user control and review, the software electronically assembles reports from inputs selected by the user from the ultrasound ABCFL during the image interpretation process. The assembled report complies with the ABCFL for ultrasound. The output may be viewed and sent to electronic storage media, or standard film or paper printers or other document manipulation programs such as Adobe or Microsoft. When used by a skilled radiologist, this device provides information that may be useful in image interpretation. Patient management decisions should not be based solely on forms generated by BRC. The ultrasound images displayed by BRC must not be used for primary diagnostic interpretation.

Source page: https://510kreport.com/device/K072258
Methodology: https://510kreport.com/methodology