# K172832: Insight BD

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Feb 6, 2018 after 140 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: 9 generations back to K904519 (1991). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152028: Volpara Imaging Software, Matakina Technologies Limited (2015) Summary page 5.

## Indications for use
Insight BD is a software application for the volumetric density assessment of digital x-ray images of the breast to aid health care professionals in the assessment of breast tissue composition. Insight BD is not a diagnostic aid and should be used only as adjunctive information when the final assessment of breast density category is made visually by medical professionals.

Source page: https://510kreport.com/device/K172832
Methodology: https://510kreport.com/methodology