510(k) Report

510(k) · Cleared

Cleared

Visage Pacs/CS, Release Version 4.1

K062490510(k) TraditionalCleared Oct 27, 200663-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mercury Computer Systems, Inc. · LLZ System, Image Processing, Radiological

Cleared on Oct 27, 2006 as substantially equivalent to K012086 (Terarecon,Inc., 2001) after a 63-day review. Its family tree reaches back 4 generations to 1995. 7 later devices descend from it.

Decided
Oct 27, 2006
Review
63 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. 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor2010: 1 descendant cleared2008: 1 descendant cleared2009: 1 descendant cleared2013: 1 descendant cleared2012: 2 descendants cleared2017: 1 descendant clearedReference device: K043483 · Radin, Model V 3.0 · Sohard AG · 2005K945188 · Cemax Vipstation and/or Software · Cemax, Inc. · 1995K961023 · Aidp (Accuimage Image Display Processor) · Accuimage, Inc. · 1996K994329 · Iivs Integrated Image Viewing Station · Terarecon,Inc. · 2000K012086 · Aquariusnet Server · Terarecon,Inc. · 20011995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants K012086 · Aquariusnet Server · Terarecon,Inc. · 2001K994329 · Iivs Integrated Image Viewing Station · Terarecon,Inc. · 2000K961023 · Aidp (Accuimage Image Display Processor) · Accuimage, Inc. · 1996K945188 · Cemax Vipstation and/or Software · Cemax, Inc. · 19950
  1. Root · 4 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
  2. 3 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
  3. 2 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
  4. 1 generation backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
  5. This deviceK062490 Visage Pacs/CS, Release Version 4.1Mercury Computer Systems, Inc. · 2006
  6. Descendant · cites it directly · 2 of its ownK080334 InstaradMedsphere Technologies Pvt, Ltd. · 2008
  7. Descendant · cites it directly · 1 of its ownK100236 Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010
  8. Descendant · cites it directly · 1 of its ownK092134 Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC · 2009
  9. Descendant · 2 generations on · 0 of its ownK171130 Nucleus Image Management SystemNucleushealth, LLC · 2017
  10. Descendant · 2 generations on · 0 of its ownK133357 Charruapacs SystemCharruasoft SA · 2013

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12012: 22013: 12017: 1
2008high 2 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all
  • K080334InstaradMedsphere Technologies Pvt, Ltd. · 2008 · cites it directly2descendants
  • K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010 · cites it directly1descendant
  • K092134Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC · 2009 · cites it directly1descendant
  • K171130Nucleus Image Management SystemNucleushealth, LLC · 2017 · 2 generations on0descendants
  • K133357Charruapacs SystemCharruasoft SA · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K945188Cemax Vipstation and/or SoftwareCemax, Inc.1995—
−3K961023Aidp (Accuimage Image Display Processor)Accuimage, Inc.1996—
−2K994329Iivs Integrated Image Viewing StationTerarecon,Inc.2000—
−1K012086Aquariusnet ServerTerarecon,Inc.2001—
0 (this device)K062490Visage Pacs/CS, Release Version 4.1Mercury Computer Systems, Inc.2006—
+1K080334InstaradMedsphere Technologies Pvt, Ltd.2008—
+1K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.2010—
+1K092134Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC2009—
+2K171130Nucleus Image Management SystemNucleushealth, LLC2017—
+2K133357Charruapacs SystemCharruasoft SA2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201220
201310
201710
FIG. 1 — Lineage of K062490, 1995–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K012086Aquariusnet Server
Summary page 6
…Equivalence comparison Chart Company Name Mercury Computer TeraRecon, Inc. Mercury Computer 510 (k) number TED K01 2086 K043483 General Networking TCP/IP Yes TCP/IP Image Acquisi-…
Terarecon,Inc.2001—
†K043483Radin, Model V 3.0Sohard AG2005—

Also cleared against K012086: 6 other devices →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080334InstaradMedsphere Technologies Pvt, Ltd.20082
K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101
K092134Stat Pacs Picture Archiving & Communication System (Pacs)Statrad, LLC20091

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 11 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, K080334 (Medsphere Technologies Pvt, Ltd., 2008) has gone furthest, with 2 descendants of its own.
  • 6 other devices also cite its predicate K012086.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

Visage PACS/CS: 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 (129 words)

Visage PACS/CS: 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.

Indications for use as stated in the FDA summary.

Also cleared against K012086

6 other devices cite the same predicate.

  • K121916IntuitionTerarecon,Inc. · 20131 recall
  • K081985AW ServerGe Medical Systems, LLC · 20085 recalls
  • K072205Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
  • K061214Aquariusaps ServerTerarecon,Inc. · 2006
  • K060035MdxnetCybermdx, Inc. · 2006
  • K051809Easyviz, Easyviz System, Easyviz Pacs System, Easyviz Image and Data Management SystemMedical Insight A/S · 2005

More from Mercury Computer Systems, Inc.

2 FDA decisions under this applicant name. See the company

  • K072205Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K062490 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062490: Visage Pacs/CS, Release Version 4.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062490

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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