510(k) · Cleared
Recalled · Class II · 2020Clearcanvas Ris / Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearcanvas, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 24, 2011 as substantially equivalent to K070080 (Intelerad Medical Systems, Inc., 2007) after a 49-day review. Its family tree reaches back 5 generations to 2001. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 24, 2011
- Review
- 49 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010259 (2001). 8 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 4 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 3 generations backK023460 PacsplusMedical Standard Co., Ltd. · 2003
- 2 generations backK032533 IntelepacsIntelerad Medical Systems, Inc. · 2003
- 1 generation backK070080 IntelepacsIntelerad Medical Systems, Inc. · 2007 · Recalled
- This deviceK110332 Clearcanvas Ris / PacsClearcanvas, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK191530 StoneCheckerImaging Biometrics, LLC · 2019
- Descendant · cites it directly · 0 of its ownK213660 RadAllyImaging Wave, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK202084 DeepLook PRECISEDeeplook, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK181460 OnePacs SystemOnepacs, LLC · 2018
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −4 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −3 | K023460 | Pacsplus | Medical Standard Co., Ltd. | 2003 | — |
| −2 | K032533 | Intelepacs | Intelerad Medical Systems, Inc. | 2003 | — |
| −1 | K070080 | Intelepacs | Intelerad Medical Systems, Inc. | 2007 | 2 |
| 0 (this device) | K110332 | Clearcanvas Ris / Pacs | Clearcanvas, Inc. | 2011 | — |
| +1 | K191530 | StoneChecker | Imaging Biometrics, LLC | 2019 | — |
| +1 | K213660 | RadAlly | Imaging Wave, LLC | 2023 | — |
| +2 | K202084 | DeepLook PRECISE | Deeplook, Inc. | 2021 | — |
| +1 | K181460 | OnePacs System | Onepacs, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K081856 | Brit Pacs Systems Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K070080 | IntelepacsSummary page 1…Montreal, OC Canada H-313 1A7 510(k) Number KOCIBS6 -' 070080, Regulation Number 892.2050 892.2050 Panel Radiolo… | 2007 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2020 | Class II | Z-1758-2020 | Under Investigation by firm | A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K191530 (Imaging Biometrics, LLC, 2019) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to…
Read the full statement (128 words)
The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.
Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications approved by the FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110332: Clearcanvas Ris / Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110332
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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