510(k) · Cleared
ClearedOnePacs System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onepacs, LLC · LLZ System, Image Processing, Radiological
Cleared on Oct 11, 2018 as substantially equivalent to K110332 (Clearcanvas, Inc., 2011) and 1 other predicate after a 129-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Oct 11, 2018
- Review
- 129 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K942120 (1994). 18 ancestors in all. 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 deviceK181460 OnePacs SystemOnepacs, LLC · 2018
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) | K181460 | OnePacs System | Onepacs, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K110332 | Clearcanvas Ris / PacsSummary page 4…Product Code LLZ Regulation Number 21 CFR 892.2050 Review Panel Radiology 3. Predicate Device ClearCanvas RIS/ PACS (K110332) OsiriX MD (K101342) 4. Device Description The OnePacs System is an image management system intended to provide… | 2011 |
| * | K101342 | Osirix MDSummary page 4…LZ Regulation Number 21 CFR 892.2050 Review Panel Radiology 3. Predicate Device ClearCanvas RIS/ PACS (K110332) OsiriX MD (K101342) 4. Device Description The OnePacs System is an image management system intended to provide scaleable DICOM compat… | 2010 |
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 24 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 18 ancestors have a recall of any class.
- 2 other devices also cite its predicate K110332.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 OnePacs System is an image management system intended 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…
Read the full statement (128 words)
The OnePacs System is an image management system intended 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 mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. For primary diagnosis, post process DICOM "for presentation" images must be used. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181460: OnePacs System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181460
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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