510(k) · Cleared
ClearedStoneChecker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Biometrics, LLC · LLZ System, Image Processing, Radiological
Cleared on Sep 26, 2019 as substantially equivalent to K141745 (Edda Technology, 2014) and 1 other predicate after a 108-day review. Its family tree reaches back 12 generations to 1991. 1 later device descends from it.
- Decided
- Sep 26, 2019
- Review
- 108 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 63 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 2 generations backK120484 Visia OncologyMeVis Medical Solutions AG · 2012
- 1 generation backK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
- This deviceK191530 StoneCheckerImaging Biometrics, LLC · 2019
- Descendant · cites it directly · 0 of its ownK202084 DeepLook PRECISEDeeplook, Inc. · 2021
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 10 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 9 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 8 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 7 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 6 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 5 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 4 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 3 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 2 generations backK120484 Visia OncologyMeVis Medical Solutions AG · 2012
- 1 generation backK141745 Iqqa-Bodyimaging SoftwareEdda Technology · 2014
- This deviceK191530 StoneCheckerImaging Biometrics, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K202084DeepLook PRECISEDeeplook, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −10 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −9 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −8 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −7 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −6 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −5 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −4 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −3 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −2 | K120484 | Visia Oncology | MeVis Medical Solutions AG | 2012 | — |
| −1 | K141745 | Iqqa-Bodyimaging Software | Edda Technology | 2014 | — |
| 0 (this device) | K191530 | StoneChecker | Imaging Biometrics, LLC | 2019 | — |
| +1 | K202084 | DeepLook PRECISE | Deeplook, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141745 | Iqqa-Bodyimaging SoftwareSummary page 4…on 510(k) Trade Name Manufacture Type Regulation Number K141745 IQQA-BodyImaging EDDA Technology Primary 892.2050 Software… | 2014 |
| * | K110332 | Clearcanvas Ris / PacsSummary page 4…Number K141745 IQQA-BodyImaging EDDA Technology Primary 892.2050 Software Predicate K110332 ClearCanvas ClearCanvas, Inc. Secondary 892.2050 RIS/PACS… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202084 | DeepLook PRECISE | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 15 of the 63 ancestors have a recall of any class.
- Of its descendants, K202084 (Deeplook, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K141745.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (101 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191530: StoneChecker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191530
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026