510(k) Report

510(k) · Cleared

Cleared

Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip

K990241510(k) TraditionalCleared Sep 23, 1999241-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

Accuimage Diagnostics Corp. · LLZ System, Image Processing, Radiological

Cleared on Sep 23, 1999 as substantially equivalent to K961023 (Accuimage, Inc., 1996) and 3 other predicates after a 241-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it.

Decided
Sep 23, 1999
Review
241 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K945188 (1995). 9 ancestors in all, the oldest K864854 (1987). 8 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 3 other ancestors1995: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor2004: 1 descendant cleared2003: 2 descendants cleared2006: 2 descendants cleared2002: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant clearedK945188 · Cemax Vipstation and/or Software · Cemax, Inc. · 1995K961023 · Aidp (Accuimage Image Display Processor) · Accuimage, Inc. · 1996K982535 · Insight Diagnostic Imaging Workstation · Neo Imagery Technologies, Inc. · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 2 descendants K982535 · Insight Diagnostic Imaging Workstation · Neo Imagery Technologies, Inc. · 1998K961023 · Aidp (Accuimage Image Display Processor) · Accuimage, Inc. · 1996K945188 · Cemax Vipstation and/or Software · Cemax, Inc. · 19950
  1. Root · 3 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
  2. 2 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
  3. 1 generation backK982535 Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998
  4. This deviceK990241 Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore…Accuimage Diagnostics Corp. · 1999
  5. Descendant · cites it directly · 1 of its ownK063221 Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006
  6. Descendant · cites it directly · 1 of its ownK024149 PrimelungAccuimage Diagnostics Corp. · 2003
  7. Descendant · 2 generations on · 0 of its ownK082336 XR-ExpressNew Mexico Software, Inc. · 2008
  8. Descendant · 2 generations on · 0 of its ownK070868 LMS-Lung/TrackMedian Technologies · 2007
  9. Descendant · cites it directly · 0 of its ownK060840 SVIEWMri Cardiac Services, Incorporated · 2006

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002: 12003: 22004: 12006: 22007: 12008: 1
2002high 2 (2003) · low 0 (2005)2026

Most influential descendants

Showing 5 of 8 · See all
  • K063221Medweb Advanced 3D Web PacsNexsys Electronics, Inc. · 2006 · cites it directly1descendant
  • K024149PrimelungAccuimage Diagnostics Corp. · 2003 · cites it directly1descendant
  • K082336XR-ExpressNew Mexico Software, Inc. · 2008 · 2 generations on0descendants
  • K070868LMS-Lung/TrackMedian Technologies · 2007 · 2 generations on0descendants
  • K060840SVIEWMri Cardiac Services, Incorporated · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K945188Cemax Vipstation and/or SoftwareCemax, Inc.1995—
−2K961023Aidp (Accuimage Image Display Processor)Accuimage, Inc.1996—
−1K982535Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc.1998—
0 (this device)K990241Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze…Accuimage Diagnostics Corp.1999—
+1K063221Medweb Advanced 3D Web PacsNexsys Electronics, Inc.2006—
+1K024149PrimelungAccuimage Diagnostics Corp.2003—
+2K082336XR-ExpressNew Mexico Software, Inc.2008—
+2K070868LMS-Lung/TrackMedian Technologies2007—
+1K060840SVIEWMri Cardiac Services, Incorporated2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199510
199730

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200320
200410
200620
200710
200810
FIG. 1 — Lineage of K990241, 1995–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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
*K961023Aidp (Accuimage Image Display Processor)
Summary page 1
…tware Package with AccuScore, AccuAnalyze, AccuScope, AccuShade, AccuVRT and AccuMIP Plug-ins 5. Substantial Equivalence Acculmage, AIDP (Acculmage Display Processor), K961023; Accu View, with AccuShade, AccuAnalyze, AccuVRT and AccuMIP. Imatron, Ultra Access, K972903; AccuScore. InSight™, Diagnostic I…
Accuimage, Inc.1996—
*K972903Imatron Ultra Access Workstation with Cardiac Software Extensions
Summary page 1
…5. Substantial Equivalence Acculmage, AIDP (Acculmage Display Processor), K961023; Accu View, with AccuShade, AccuAnalyze, AccuVRT and AccuMIP. Imatron, Ultra Access, K972903; AccuScore. InSight™, Diagnostic Irriaging Workstation, K982535,and Picker, Voxel Q, Voyager, K962010; AccuScope. === Page 2 ==…
Imatron, Inc.1997—
*K982535Insight Diagnostic Imaging Workstation
Summary page 1
…rocessor), K961023; Accu View, with AccuShade, AccuAnalyze, AccuVRT and AccuMIP. Imatron, Ultra Access, K972903; AccuScore. InSight™, Diagnostic Irriaging Workstation, K982535,and Picker, Voxel Q, Voyager, K962010; AccuScope. 6. Device Description and Intended Use The AccuView Diagnostic…
Neo Imagery Technologies, Inc.1998—
*K962010Epi-Scope Option for Q Series CT Systems
Summary page 1
…cuShade, AccuAnalyze, AccuVRT and AccuMIP. Imatron, Ultra Access, K972903; AccuScore. InSight™, Diagnostic Irriaging Workstation, K982535,and Picker, Voxel Q, Voyager, K962010; AccuScope. 6. Device Description and Intended Use The AccuView Diagnostic Imaging Workstation Software Package…
Philips Medical Systems (Cleveland), Inc.1997—

Also cleared against K961023: 9 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K063221Medweb Advanced 3D Web PacsNexsys Electronics, Inc.20061
K024149PrimelungAccuimage Diagnostics Corp.20031
K060840SVIEWMri Cardiac Services, Incorporated20060
K040782N-Vivo Calcium Score on IA Chassis Release, Model Release X.XXImage Analysis, Inc.20040
K032546Hologic DR ImageproHologic, Inc.20030
K021913Calscor Software3D Med Co., Ltd.20020

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 4 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K063221 (Nexsys Electronics, Inc., 2006) has gone furthest, with 1 descendant of its own.
  • 9 other devices also cite its predicate K961023.

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?

The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all “off-the-shelf” standard computer components and may be purchased independently by the end user of supplied by AccuImage. The AccuImage, AccuView software receives image files from medical scanning devices, such as CT or MRI and perform real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving,

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K961023

9 other devices cite the same predicate.

  • K041286Dynacad V1.0Mri Devices Corp. · 2004
  • K031779CadstreamConfirma, Inc. · 2003
  • K994329Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
  • K994054Issa PharosVams Tec, D.O.O. · 2000
  • K992354SNT Image Analysis SystemSurgical Navigation Technologies, Inc. · 1999
  • K982535Insight Diagnostic Imaging WorkstationNeo Imagery Technologies, Inc. · 1998

More from Accuimage Diagnostics Corp.

3 FDA decisions under this applicant name. See the company

  • K024149PrimelungAccuimage Diagnostics Corp. · 2003
  • K012106Accuimage Smartgate UpgradeAccuimage Diagnostics Corp. · 2001

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/K990241 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990241: Accuimage, Accuview Diagnostic Imaging, Workstation W/Accuscore, Accuanalyze, Accuscope, Accushade, Accuvrt, and Accumip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990241

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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