510(k) · Cleared
ClearedVisage Pacs/CS, Release Version 5.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Computer Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 29, 2007 as substantially equivalent to K012086 (Terarecon,Inc., 2001) after a 21-day review. Its family tree reaches back 4 generations to 1995. 36 later devices descend from it.
- Decided
- Aug 29, 2007
- Review
- 21 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945188 (1995). 5 ancestors in all. 36 later devices descend from it, 4 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 deviceK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
- Descendant · cites it directly · 20 of its ownK082269 Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK082430 Syngo Imaging XSSiemens AG Medical Solutions · 2008 · Recalled
- Descendant · 2 generations on · 10 of its ownK093612 Syngo.PlazaSiemens AG Medical Solutions · 2010 · Recalled
- Descendant · 3 generations on · 9 of its ownK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- Descendant · 4 generations on · 8 of its ownK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K082269Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008 · cites it directly20descendants
- K082430Syngo Imaging XSSiemens AG Medical Solutions · 2008 · cites it directly11descendants
- K093612Syngo.PlazaSiemens AG Medical Solutions · 2010 · 2 generations on10descendants
- K101666Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · 3 generations on9descendants
- K132532Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · 4 generations on8descendants
View 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) | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
| +1 | K082269 | Visage Pacs, Version 6.0/CS 3.1 | Visage Imaging, Inc. | 2008 | — |
| +1 | K082430 | Syngo Imaging XS | Siemens AG Medical Solutions | 2008 | 12 |
| +2 | K093612 | Syngo.Plaza | Siemens AG Medical Solutions | 2010 | 16 |
| +3 | K101666 | Syngo. Plaza VA20A | Siemens AG Medical Solutions | 2010 | 3 |
| +4 | K132532 | Syngo.Plaza VB10A | Siemens AG Healthcare | 2013 | 11 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K012086 | Aquariusnet ServerSummary page 1…ntially equivalent, in the opinion of Mercury Computer Systems Inc., to: Trade name: AquariusNet Server/Thin client 510(k) No.: K012086 Mercury Computer Systems, Inc. E-1 Premarket Submission… | 2001 |
What descends from it? (36)
See all 364 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 12 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K082269 (Visage Imaging, Inc., 2008) has gone furthest, with 20 descendants of its own.
- 6 other devices also cite its predicate K012086.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Visage PACS is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components: Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data. Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed…
Read the full statement (163 words)
Visage PACS is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components:
Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data.
Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients.
Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities.
Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.
Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072205 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072205: Visage Pacs/CS, Release Version 5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072205
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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