510(k) · Cleared
ClearedEasyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Insight A/S · LLZ System, Image Processing, Radiological
Cleared on Aug 15, 2005 as substantially equivalent to K042292 (Stentor, Inc., 2004) and 2 other predicates after a 41-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 15, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945188 (1995). 11 ancestors in all, the oldest K920319 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 3 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 2 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 1 generation backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- This deviceK051809 Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data…Medical Insight A/S · 2005
- Descendant · cites it directly · 1 of its ownK063392 Imco-StatImco Technologies · 2006
- Descendant · 2 generations on · 0 of its ownK112480 View 1 ImagingKarl Storz Endoscopy America, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −3 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −2 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −1 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| 0 (this device) | K051809 | Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data… | Medical Insight A/S | 2005 | — |
| +1 | K063392 | Imco-Stat | Imco Technologies | 2006 | — |
| +2 | K112480 | View 1 Imaging | Karl Storz Endoscopy America, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K042292 | Isite PacsSummary page 2…Medical Insight 02iY' 1.5 Substantial Equivalence The EasyViz(tm) has the same intended uses (K042292) and technical and characteristics… | 2004 |
| * | K011142 | Aquarius WorkstationSummary page 2…ite Radiology System, and the Terarecon Aquarius Workstation and Aquariusnet (K011142 K012086 respectively). 1.6 Device Description and Intended Use… | 2001 |
| * | K012086 | Aquariusnet ServerSummary page 2…and the Terarecon Aquarius Workstation and Aquariusnet (K011142 K012086 respectively). 1.6 Device Description and Intended Use… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063392 | Imco-Stat | 2006 | 1 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K063392 (Imco Technologies, 2006) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K042292.
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?
The Medical Insight EasyVizTM PACS System is a Diagnostic Softcopy Reading software package to be used for primary diagnostic clinical review of digital radiology images. The product utilizes the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows XP, Linux). The product interfaces to existing…
Read the full statement (139 words)
The Medical Insight EasyVizTM PACS System is a Diagnostic Softcopy Reading software package to be used for primary diagnostic clinical review of digital radiology images.
The product utilizes the conventional TCP/IP internetworking infrastructure available in most healthcare organizations, and it uses commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows XP, Linux).
The product interfaces to existing imaging equipment using the DICOM PS 3.1-2000 (Digital Imaging And Communications In Medicine) standard communication protocol as described and developed by ACR.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 M-pixel resolution and meets other technical specifications reviewed and accepted by the US FDA.
The system does not permanently store or produce original medical images.
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/K051809 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051809: Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051809
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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