510(k) · Cleared
ClearedVM Pacs with VM Medical Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visual Medica · LLZ System, Image Processing, Radiological
Cleared on Jan 16, 2015 as substantially equivalent to K123174 (GE Healthcare, 2012) after a 218-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jan 16, 2015
- Review
- 218 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K942120 (1994). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 6 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 5 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 4 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 3 generations backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 2 generations backK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · Recalled
- 1 generation backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- This deviceK141561 VM Pacs with VM Medical WorkstationVisual Medica · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −6 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −5 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −4 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −3 | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | 7 |
| −2 | K121387 | Centricity Pacs-IW | Ge Healthcare Integrated IT Solutions | 2012 | 1 |
| −1 | K123174 | Centricity Pacs-IW with Universal Viewer | GE Healthcare | 2012 | 10 |
| 0 (this device) | K141561 | VM Pacs with VM Medical Workstation | Visual Medica | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K123174 | Centricity Pacs-IW with Universal ViewerSummary page 4…Pro duct C o de: LLZ P RE D I C A T E D E V I C E : 510 (k) Number Model Name Manufacturer K123174 C ENTRICITY PACS-IW WITH UN I V E RSA L V I E WE R GE HE A L T H C A RE 1.1 Device Descrip… | 2012 |
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 21 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 14 ancestors have a recall of any class.
- 5 other devices also cite its predicate K123174.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
VM PACS is designed to Store Medical Dicom Images and leave them available to be used for diagnostics or transferred to other Dicom devices. VM PACS is not meant to create or modify DICOM images. VM PACS store the images and the Data Set send by an DICOM compatible image diagnostic equipment and store them making them available to be access by a workstation or viewer, or been transfer to another Dicom Compatible device. VM PACS does not modify the images…
Read the full statement (239 words)
VM PACS is designed to Store Medical Dicom Images and leave them available to be used for diagnostics or transferred to other Dicom devices.
VM PACS is not meant to create or modify DICOM images. VM PACS store the images and the Data Set send by an DICOM compatible image diagnostic equipment and store them making them available to be access by a workstation or viewer, or been transfer to another Dicom Compatible device.
VM PACS does not modify the images store in it.
User Graphic interface VM Medical Workstation is a complete Workstation which provides diagnostic tools for image diagnose, for CT, MR, PT, CR, DX, NM, MG, XA, RF, SC, US and ES, as zoom, Window & Level variation and presets, measurements and a complete set of diagnostics tools and includes a report tool for the studies.
Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.
VM Clinical Viewer is the web access interface of VM PACS, which allows integration with any Operating System, brings to the institution the capacity to access the images remotely.
VM Clinical Viewer allows the specialist consultation and the communication between radiologists and referring physicians. The system enables authorized external users to have access to specific patient studies, is not intended for diagnostic purposes when used on mobile devices.
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/K141561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141561: VM Pacs with VM Medical Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141561
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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