510(k) · Cleared
ClearedAvreo Interworks System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avreo, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 2, 2014 as substantially equivalent to K070755 (Avreo, Inc., 2007) after a 20-day review. Its family tree reaches back 6 generations to 1993.
- Decided
- Jul 2, 2014
- Review
- 20 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924178 (1993). 21 ancestors in all, the oldest K920309 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 5 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- 4 generations backK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
- 3 generations backK033831 Sienet CosmosSiemens AG Medical Solutions · 2003 · Recalled
- 2 generations backK042832 Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · Recalled
- 1 generation backK070755 InterworksAvreo, Inc. · 2007
- This deviceK141556 Avreo Interworks SystemAvreo, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −5 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| −4 | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −3 | K033831 | Sienet Cosmos | Siemens AG Medical Solutions | 2003 | 1 |
| −2 | K042832 | Sienet Cosmos (Version V15A) | Siemens AG Medical Solutions | 2004 | 3 |
| −1 | K070755 | Interworks | Avreo, Inc. | 2007 | — |
| 0 (this device) | K141556 | Avreo Interworks System | Avreo, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K070755 | InterworksSummary page 1…ure Archiving, and Communications System (PACS) (21 CFR 892.2050, Product Code LLZ) V. Predicate Device: K070755 interWORKS Class 11 Decision Date: 05/08/2007 VI. Device Description and Label: lnterWorksTM… | 2007 |
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 5 companies; a new generation was cleared every 4.1 years on median.
- 7 of the 21 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
interWORKS is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and Images from a variety of different modality and Information systems. This also includes the display of structured reports and mammography Images that have been created according to DICOM "For Presentation", and will Include standard features and other Mammno tools. Lossy compressed…
Read the full statement (136 words)
interWORKS is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and Images from a variety of different modality and Information systems. This also includes the display of structured reports and mammography Images that have been created according to DICOM "For Presentation", and will Include standard features and other Mammno tools. Lossy compressed mammography Images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.
Application areas Include Imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured In the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141556: Avreo Interworks System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141556
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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