510(k) · Cleared
ClearedLSN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imaging Biometrics, LLC · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 29, 2020 as substantially equivalent to K133649 (GE Medical Systems SCS, 2014) and 1 other predicate after a 189-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Oct 29, 2020
- Review
- 189 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K942120 (1994). 18 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 7 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 6 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 5 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 4 generations backK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- 3 generations backK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- 2 generations backK063470 Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007
- 1 generation backK101342 Osirix MDPixmeo Sarl · 2010
- This deviceK201092 LSNImaging Biometrics, LLC · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −7 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −6 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −5 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −4 | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| −3 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| −2 | K063470 | Aycan Workstation Osirix | Aycan Digitalsysteme GmbH | 2007 | — |
| −1 | K101342 | Osirix MD | Pixmeo Sarl | 2010 | — |
| 0 (this device) | K201092 | LSN | Imaging Biometrics, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2014 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K133649 | Hepatic VcarSummary page 4…(21 CFR) Code Primary Predicate K133649 Hepatic VCAR GE Medical Systems SCS 892.1750 System, X-Ray, Tomography, Computed II JAK Secondary… | 2014 |
| * | K101342 | Osirix MDSummary page 4…Primary Predicate K133649 Hepatic VCAR GE Medical Systems SCS 892.1750 System, X-Ray, Tomography, Computed II JAK Secondary K101342 OsiriX MD Pixmeo SARL 892.2050 System, Image Processing, Radiological II LLZ Predicate… | 2010 |
| † | K041521 | Volume Viewer Plus | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K133649.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
LSN (Liver Surface Nodularity) is an image analysis software application intended to assist radiologists and other trained healthcare professionals in analyzing and reporting on the liver morphology depicted in computed tomography (CT) images for use in assessment of chronic liver disease. LSN is designed to assist the user in the evaluation and documentation of liver morphology, specifically liver surface nodularity, provided that the surface nodularity…
Read the full statement (180 words)
LSN (Liver Surface Nodularity) is an image analysis software application intended to assist radiologists and other trained healthcare professionals in analyzing and reporting on the liver morphology depicted in computed tomography (CT) images for use in assessment of chronic liver disease. LSN is designed to assist the user in the evaluation and documentation of liver morphology, specifically liver surface nodularity, provided that the surface nodularity is adequately depicted on the CT images.
LSN provides quantitative metrics related to liver fibrosis by automating segmentation of the liver surface within user-defined Regions of Interest (ROIs) and calculating distances and means related to the liver surface nodularity. LSN also offers reporting capabilities for documenting user-confirmed results, thereby facilitating communication with other trained healthcare professionals and assessment of changes over time.
LSN is intended to provide image-related information that is interpreted by a trained professional, but it does not directly generate any diagnosis. The information provided by LSN should not be used in isolation when making patient management decisions.
LSN is not intended for use with or for the diagnostic interpretation of mammography images.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201092: LSN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201092
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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