510(k) · Cleared
ClearedXviewnet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Radiologist Network, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 22, 2008 as substantially equivalent to K013630 (Stentor, Inc., 2001) and 1 other predicate after an 18-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Feb 22, 2008
- Review
- 18 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K942120 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 2 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 1 generation backK030751 Ipacs PrismRealtimeimage, Inc. · 2003
- This deviceK080290 XviewnetAmerican Radiologist Network, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK081792 Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −2 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −1 | K030751 | Ipacs Prism | Realtimeimage, Inc. | 2003 | — |
| 0 (this device) | K080290 | Xviewnet | American Radiologist Network, Inc. | 2008 | — |
| +1 | K081792 | Spy Analysis Toolkit, Model SA9000 | Novadaq Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 21.6 · 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 |
|---|---|---|---|
| * | K013630 | Isite Radiology | 2001 |
| * | K030751 | Ipacs PrismSummary page 1…wNet PACS is substantially equivalent to the following predicate devices: * iSite Radiology (KO13630) from Stentor Inc. * iPACS Prism (K030751) from Real Time Image Inc. IV. Intended Use of the Device The xViewNet software is intended as a display and analy… | 2003 |
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 |
|---|---|---|---|
| K081792 | Spy Analysis Toolkit, Model SA9000 | 2008 | 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 14 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K081792 (Novadaq Technologies, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K013630.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
xViewNet is a secured imaging software system that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
This device is not intended for mammography use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080290 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080290: Xviewnet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080290
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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