510(k) · Cleared
ClearedPacsplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Standard Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jan 9, 2003 as substantially equivalent to K012844 (Marotech, Inc., 2001) after an 86-day review. Its family tree reaches back 2 generations to 2001. 16 later devices descend from it.
- Decided
- Jan 9, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010259 (2001). 16 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 1 generation backK012844 Marosis PacsMarotech, Inc. · 2001
- This deviceK023460 PacsplusMedical Standard Co., Ltd. · 2003
- Descendant · cites it directly · 7 of its ownK032533 IntelepacsIntelerad Medical Systems, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK042311 PacspartnerMedical Standard Co., Ltd. · 2004
- Descendant · cites it directly · 5 of its ownK070080 IntelepacsIntelerad Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 4 of its ownK110332 Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK073062 Omni-Vue SystemGenesis Digital Imaging, Inc. · 2008
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K032533IntelepacsIntelerad Medical Systems, Inc. · 2003 · cites it directly7descendants
- K042311PacspartnerMedical Standard Co., Ltd. · 2004 · cites it directly6descendants
- K070080IntelepacsIntelerad Medical Systems, Inc. · 2007 · cites it directly5descendants
- K110332Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · 2 generations on4descendants
- K073062Omni-Vue SystemGenesis Digital Imaging, Inc. · 2008 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −1 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| 0 (this device) | K023460 | Pacsplus | Medical Standard Co., Ltd. | 2003 | — |
| +1 | K032533 | Intelepacs | Intelerad Medical Systems, Inc. | 2003 | — |
| +1 | K042311 | Pacspartner | Medical Standard Co., Ltd. | 2004 | — |
| +1 | K070080 | Intelepacs | Intelerad Medical Systems, Inc. | 2007 | 2 |
| +2 | K110332 | Clearcanvas Ris / Pacs | Clearcanvas, Inc. | 2011 | 1 |
| +2 | K073062 | Omni-Vue System | Genesis Digital Imaging, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K012844 | Marosis Pacs | 2001 |
What descends from it? (16)
See all 164 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)
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 2 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032533 (Intelerad Medical Systems, Inc., 2003) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K012844.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
PACSPLUS is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023460: Pacsplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023460
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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