510(k) Report

510(k) · Cleared

Cleared

Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print Spooler, Analog & Digital Acquire

K955092510(k) TraditionalCleared May 9, 1996184-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

Cemax-Icon, Inc. · LLZ System, Image Processing, Radiological

Cleared on May 9, 1996 after a 184-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 219 later devices descend from it.

Decided
May 9, 1996
Review
184 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

219 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2003: 7 descendants cleared2001: 2 descendants cleared1998: 1 descendant cleared2002: 2 descendants cleared2004: 3 descendants cleared2008: 7 descendants cleared2012: 9 descendants cleared2006: 3 descendants cleared2010: 9 descendants cleared2011: 10 descendants cleared2007: 3 descendants cleared2005: 9 descendants cleared1997: 1 descendant cleared2009: 5 descendants cleared2014: 7 descendants cleared2013: 8 descendants cleared1999: 1 descendant cleared2026: 15 descendants cleared2020: 11 descendants cleared2017: 12 descendants cleared2016: 8 descendants cleared2024: 15 descendants cleared2015: 10 descendants cleared2022: 8 descendants cleared2018: 14 descendants cleared2019: 6 descendants cleared2021: 7 descendants cleared2023: 13 descendants cleared2025: 12 descendants cleared1995200020052010201520202025
  1. This deviceK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
  2. Descendant · cites it directly · 123 of its ownK013630 Isite RadiologyStentor, Inc. · 2001
  3. Descendant · 2 generations on · 115 of its ownK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
  4. Descendant · 3 generations on · 114 of its ownK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
  5. Descendant · cites it directly · 64 of its ownK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
  6. Descendant · 2 generations on · 61 of its ownK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002

Showing 5 of 219 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 11999: 12001: 22002: 22003: 72004: 32005: 92006: 32007: 32008: 72009: 52010: 92011: 102012: 92013: 82014: 72015: 102016: 82017: 122018: 142019: 62020: 112021: 72022: 82023: 132024: 152025: 122026: 15
1996high 15 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 219 · See all
  • K013630Isite RadiologyStentor, Inc. · 2001 · cites it directly123descendants
  • K031311Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003 · 2 generations on115descendants
  • K042313Integradweb MPR/MipDynamic Imaging, Inc. · 2004 · 3 generations on114descendants
  • K012093Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001 · cites it directly64descendants
  • K013694Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002 · 2 generations on61descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955092Accurad Image Management System, Autorad, Regustration Station, Archive…Cemax-Icon, Inc.1996—
+1K013630Isite RadiologyStentor, Inc.2001—
+2K031311Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc.2003—
+3K042313Integradweb MPR/MipDynamic Imaging, Inc.2004—
+1K012093Aetmed Image Processing SoftwareAetmed, S.P.A.2001—
+2K013694Nidek Advanced Vision Information System (Navis)Nidek, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
199910
200120
200220
200370
200430
200590
200630
200730
200870
200950
201090
2011100
201290
201380
201470
2015100
201680
2017120
2018140
201960
2020110
202170
202280
2023130
2024150
2025120
2026150
FIG. 1 — Lineage of K955092, 1996–2026Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (219)

See all 219

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

NumberDeviceApplicantDecidedDescendants
K013630Isite RadiologyStentor, Inc.2001123
K012093Aetmed Image Processing SoftwareAetmed, S.P.A.200164
K963610Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc.199631
K982563Ultrapro Model 98Ramsoft, Inc.19987
K031562Ramsoft Pacs, Model 3.0Ramsoft, Inc.20036

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?

  • Of its descendants, K013630 (Stentor, Inc., 2001) has gone furthest, with 123 descendants of its own.

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—

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/K955092 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955092: Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print Spooler, Analog & Digital Acquire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955092

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026