510(k) · Cleared
ClearedOnis-Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digitalcore Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Aug 13, 2018 as substantially equivalent to K062488 (Image Information Systems, Ltd., 2006) after an 87-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.
- Decided
- Aug 13, 2018
- Review
- 87 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K942120 (1994). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 4 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 3 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 2 generations backK052358 Etiam Star Pacs ComponentsEtiam, S.A. · 2005
- 1 generation backK062488 IQ-System Pacs SystemImage Information Systems, Ltd. · 2006
- This deviceK181318 Onis-PacsDigitalcore Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK261874 Syneris PACS v.1.0.1.0Syneris · 2026
Most influential descendants
Showing 1 of 1 · See all- K261874Syneris PACS v.1.0.1.0Syneris · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −5 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −4 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −3 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −2 | K052358 | Etiam Star Pacs Components | Etiam, S.A. | 2005 | — |
| −1 | K062488 | IQ-System Pacs System | Image Information Systems, Ltd. | 2006 | — |
| 0 (this device) | K181318 | Onis-Pacs | Digitalcore Co., Ltd. | 2018 | — |
| +1 | K261874 | Syneris PACS v.1.0.1.0 | Syneris | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K062488 | IQ-System Pacs SystemSummary page 4…ification of Predicate Devices Device Name iQ-System PACS Manufacturer IMAGE Information Systems Ltd 510(k) Number K062488 Regulatory Class Class II Common Name Picture Archiving and Communication System Clearance D… | 2006 |
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 |
|---|---|---|---|
| K261874 | Syneris PACS v.1.0.1.0 | 2026 | 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 24 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K261874 (Syneris, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K062488.
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?
ONIS-PACS is a software device intended to be used by healthcare personnel and intended for viewing,
reviewing, performing measurements/quantifications and reporting of medical images and data acquired from DICOM
compliant medical imaging systems. Images and data can be stored, communicated, processed and displayed within the
system or across computer networks at distributed locations. Lossy images and digitized film images must not be used for
primary diagnosis or interpretation.
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/K181318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181318: Onis-Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181318
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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