510(k) · Cleared
ClearedUnipacs Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Universal Pacs, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 7, 2003 as substantially equivalent to K012211 (Efilm Medical, Inc., 2001) after an 83-day review. Its family tree reaches back 4 generations to 1990. 12 later devices descend from it.
- Decided
- Jan 7, 2003
- Review
- 83 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896095 (1990). 5 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 3 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 2 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 1 generation backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- This deviceK023476 Unipacs WorkstationUniversal Pacs, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK081304 Alz Web Pacs, Version 1.0Alz, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK130624 CONIGlobalmed · 2013
- Descendant · 3 generations on · 4 of its ownK153653 DICOM ViewerBrainlab AG · 2016
- Descendant · 4 generations on · 3 of its ownK191014 Elements ViewerBrainlab AG · 2020
- Descendant · cites it directly · 2 of its ownK071894 Xebra Dicom Image BrowserHx Technologies, Inc. · 2007
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K081304Alz Web Pacs, Version 1.0Alz, Inc. · 2008 · cites it directly8descendants
- K130624CONIGlobalmed · 2013 · 2 generations on7descendants
- K153653DICOM ViewerBrainlab AG · 2016 · 3 generations on4descendants
- K191014Elements ViewerBrainlab AG · 2020 · 4 generations on3descendants
- K071894Xebra Dicom Image BrowserHx Technologies, Inc. · 2007 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −3 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −2 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −1 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| 0 (this device) | K023476 | Unipacs Workstation | Universal Pacs, Inc. | 2003 | — |
| +1 | K081304 | Alz Web Pacs, Version 1.0 | Alz, Inc. | 2008 | — |
| +2 | K130624 | CONI | Globalmed | 2013 | — |
| +3 | K153653 | DICOM Viewer | Brainlab AG | 2016 | — |
| +4 | K191014 | Elements Viewer | Brainlab AG | 2020 | — |
| +1 | K071894 | Xebra Dicom Image Browser | Hx Technologies, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K012211 | Efilm WorkstationSummary page 1…Picture Archiving and Communications System Classification Name: PACS (per 2 1 CFR 892.2050), LLZ, Class I1 Substantially EquivalentTo eFilm Workstation (k012211, see also k020995)) eFilm Medical Inc. 500 University Ave, Suite 300 Toronto, Ontario Canada M5G 1V7 www.efilm.ca… | 2001 |
What descends from it? (12)
See all 122 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 13 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K081304 (Alz, Inc., 2008) has gone furthest, with 8 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.
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?
UniPACS Workstation software is intended to be used as a fully-functional, PC-based PACS software application, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
Typical users of this system are trained professionals, including but not limited to physicians, nurses and technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023476: Unipacs Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023476
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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