510(k) · Cleared
ClearedPacspartner
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 Sep 9, 2004 as substantially equivalent to K023460 (Medical Standard Co., Ltd., 2003) after a 14-day review. Its family tree reaches back 3 generations to 2001. 6 later devices descend from it.
- Decided
- Sep 9, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010259 (2001). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 2 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 1 generation backK023460 PacsplusMedical Standard Co., Ltd. · 2003
- This deviceK042311 PacspartnerMedical Standard Co., Ltd. · 2004
- Descendant · cites it directly · 3 of its ownK073062 Omni-Vue SystemGenesis Digital Imaging, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK092235 Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK130374 Omni-Vue 2 SystemGenesis Digital Imaging, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK102435 Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK083658 Pacs Plus 5TH EditionMedical Standard Co., Ltd. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K073062Omni-Vue SystemGenesis Digital Imaging, Inc. · 2008 · cites it directly3descendants
- K092235Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2009 · 2 generations on1descendant
- K130374Omni-Vue 2 SystemGenesis Digital Imaging, Inc. · 2013 · 2 generations on0descendants
- K102435Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2010 · 3 generations on0descendants
- K083658Pacs Plus 5TH EditionMedical Standard Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −2 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −1 | K023460 | Pacsplus | Medical Standard Co., Ltd. | 2003 | — |
| 0 (this device) | K042311 | Pacspartner | Medical Standard Co., Ltd. | 2004 | — |
| +1 | K073062 | Omni-Vue System | Genesis Digital Imaging, Inc. | 2008 | — |
| +2 | K092235 | Beyondimage Workstation | Neusoft Medical Systems Co., Ltd. | 2009 | — |
| +2 | K130374 | Omni-Vue 2 System | Genesis Digital Imaging, Inc. | 2013 | — |
| +3 | K102435 | Beyondimage Workstation | Neusoft Medical Systems Co., Ltd. | 2010 | — |
| +1 | K083658 | Pacs Plus 5TH Edition | Medical Standard Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K023460 | PacsplusSummary page 1…e Device: 21 CFR 807. 92(a)(3) Device Classification Name system, image processing, radiological 510(k) Number K023460 Regulation Number 892.2050 Class II Device Name PACSPlusTM… | 2003 |
What descends from it? (6)
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)
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 3 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073062 (Genesis Digital Imaging, Inc., 2008) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K023460.
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?
PACSPartnerTM is software 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. Options make possible reading (including…
Read the full statement (126 words)
PACSPartnerTM is software 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.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. 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/K042311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042311: Pacspartner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042311
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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