510(k) · Cleared
ClearediCAS-LV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Highrad, Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Mar 1, 2024 as substantially equivalent to K061696 (Edda Technology, Inc., 2006) after a 266-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Mar 1, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 14 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 2 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 1 generation backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- This deviceK231690 iCAS-LVHighrad, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −2 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −1 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| 0 (this device) | K231690 | iCAS-LV | Highrad, Ltd. | 2024 | — |
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 |
| 2004 | 2 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K061696 | Iqqa-Liver SoftwareSummary page 4…gulatory Class: Class II Product Code: QIH Regulation: 21 CFR 892.2050 Predicate Device: IQQA-LIVER Software from EDDA Technology, Inc. (K061696) Device Description The iCAS-LV (iCAS hereafter) provides tools for interactive segmentation of radiologist-identified liver le… | 2006 |
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 28 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 6 other devices also cite its predicate K061696.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
The iCAS -LV is intended to receive multi-phase volume datasets of reconstructed studies from PACS devices, to process them and to transfer the processing output to the PACS in DICOM format. It is a PC-based, self-contained, noninvasive image analysis software application. The device provides tools for visualization, measurements, segmentation, annotation, images registration, processing, and reporting. The device is intended for use by trained…
Read the full statement (131 words)
The iCAS -LV is intended to receive multi-phase volume datasets of reconstructed studies from PACS devices, to process them and to transfer the processing output to the PACS in DICOM format. It is a PC-based, self-contained, noninvasive image analysis software application. The device provides tools for visualization, measurements, segmentation, annotation, images registration, processing, and reporting.
The device is intended for use by trained physicians. Further, the iCAS-LV is indicated to support the physicians in visualization of CT reconstructed images and evaluation of physician-identified liver lesions. The combination of the visualization, interactive segmentation, measurements, automatic registration, and volumetric analysis, supports the physician in evaluation of the lesions in terms of size, shape, position and changes over time. The iCAS should not be used in isolation for diagnosis and making patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231690: iCAS-LV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231690
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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