# K191530: StoneChecker

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Biometrics, LLC
- Decided: Sep 26, 2019 after 108 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: 12 generations back to K913770 (1991). 63 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141745: Iqqa-Bodyimaging Software, Edda Technology (2014) Summary page 4.
- K110332: Clearcanvas Ris / Pacs, Clearcanvas, Inc. (2011) Summary page 4.

## Most influential descendants
- K202084: DeepLook PRECISE (2021), 0 descendants of its own

## Indications for use
StoneChecker is a standalone post-processing software application which assists trained professionals in evaluating DICOM computed tomography image studies of patients diagnosed with kidney stones. The software provides tools to enable the user to navigate images, select regions of interest, and generate information from those regions. The generated information consists of regional statistical measurements of image texture and heterogeneity, including means, standard deviation, skewness, and kurtosis. The information also includes regional physical measurements of stone size, volume, and position. StoneChecker does not make clinical decisions and the information provided by StoneChecker must not be used in isolation when making patient management decisions.

Source page: https://510kreport.com/device/K191530
Methodology: https://510kreport.com/methodology