510(k) · Cleared
ClearedBeyondimage Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neusoft Medical Systems Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Aug 6, 2009 as substantially equivalent to K012211 (Efilm Medical, Inc., 2001) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Aug 6, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010259 (2001). 10 ancestors in all, the oldest K896095 (1990). 1 later device descends from it, 1 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 backK042311 PacspartnerMedical Standard Co., Ltd. · 2004
- 1 generation backK073062 Omni-Vue SystemGenesis Digital Imaging, Inc. · 2008
- This deviceK092235 Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK102435 Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K102435Beyondimage WorkstationNeusoft Medical Systems Co., Ltd. · 2010 · cites it directly0descendants
View 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 | K042311 | Pacspartner | Medical Standard Co., Ltd. | 2004 | — |
| −1 | K073062 | Omni-Vue System | Genesis Digital Imaging, Inc. | 2008 | — |
| 0 (this device) | K092235 | Beyondimage Workstation | Neusoft Medical Systems Co., Ltd. | 2009 | — |
| +1 | K102435 | Beyondimage Workstation | Neusoft Medical Systems Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K012211 | Efilm WorkstationSummary page 2…cannot receive, display and process the images with non-DICOM3.0 format. BeyondImage Workstation cannot display and process mammograms. Predicate Device: K012211: eFilm Workstation K073062: Omni-Vue System Statement of Substantial Equivalence: The BeyondImage Workstation is compar… | 2001 |
| * | K073062 | Omni-Vue SystemSummary page 2…ocess the images with non-DICOM3.0 format. BeyondImage Workstation cannot display and process mammograms. Predicate Device: K012211: eFilm Workstation K073062: Omni-Vue System Statement of Substantial Equivalence: The BeyondImage Workstation is comparable and substantially equival… | 2008 |
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 |
|---|---|---|---|
| K102435 | Beyondimage Workstation | 2010 | 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 8 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K102435 (Neusoft Medical Systems Co., Ltd., 2010) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K012211.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
BeyondImage Workstation is a software application that is used for viewing medical images. Beyondlmage Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and digital radiographic devices). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing…
Read the full statement (154 words)
BeyondImage Workstation is a software application that is used for viewing medical images. Beyondlmage Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and digital radiographic devices). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to adjustment of window width and center; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. Italso provides standard Multi-Planar Reformation (MPR) views and 3D views of Volume Rendering for digital images from CT, MR, and PET unit. In addition, using BeyondImage Workstation, users can edit and print report. Beyondlmage Workstation cannot display and process mammograms.
Typical users of BeyondImage Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092235: Beyondimage Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092235
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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