510(k) Report

510(k) · Cleared

Cleared

Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak Directview CX/DX, Kodak Directvib

K030781510(k) TraditionalCleared May 29, 200379-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

Eastman Kodak Company · LLZ System, Image Processing, Radiological

Cleared on May 29, 2003 after a 79-day review. The FDA summary names its predicate without a number. 20 later devices descend from it.

Decided
May 29, 2003
Review
79 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

20 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 2 descendants cleared2005: 2 descendants cleared2006: 2 descendants cleared2013: 1 descendant cleared2012: 2 descendants cleared2010: 1 descendant cleared2009: 1 descendant cleared2011: 2 descendants cleared2018: 3 descendants cleared2016: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK030781 Kodak Directview Pacs/Image Management System, Kodak Directview…Eastman Kodak Company · 2003
  2. Descendant · cites it directly · 15 of its ownK042292 Isite PacsStentor, Inc. · 2004 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK063267 Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co. · 2006 · Recalled
  4. Descendant · 3 generations on · 5 of its ownK111804 Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 2011 · Recalled
  5. Descendant · 4 generations on · 3 of its ownK160315 I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016
  6. Descendant · 5 generations on · 2 of its ownK173588 Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 22007: 22009: 12010: 12011: 22012: 22013: 12016: 12018: 32025: 12026: 1
2004high 3 (2018) · low 0 (2008)2026

Most influential descendants

Showing 5 of 20 · See all
  • K042292Isite PacsStentor, Inc. · 2004 · cites it directly15descendants
  • K063267Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co. · 2006 · 2 generations on8descendants
  • K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 2011 · 3 generations on5descendants
  • K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016 · 4 generations on3descendants
  • K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030781Kodak Directview Pacs/Image Management System, Kodak Directview Workflow…Eastman Kodak Company2003—
+1K042292Isite PacsStentor, Inc.20047
+2K063267Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co.20064
+3K111804Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc.20112
+4K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V.2016—
+5K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200620
200720
200910
201010
201120
201220
201310
201610
201830
202510
202610
FIG. 1 — Lineage of K030781, 2003–2026Source: 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), 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? (2)

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
*—AccuRad
Named without a submission number
—
*—Archive Manager
Named without a submission number
—

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K042292Isite PacsStentor, Inc.200415
K062878Ezpacs, Version 3.0Advanced Imaging Solutions, LLC20072
K063294TopacsRadiological Specialists, Inc.20070

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, K042292 (Stentor, Inc., 2004) has gone furthest, with 15 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—

What is it indicated for?

The Kodak Directview PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities and information systems.

Indications for use as stated in the FDA summary.

More from Eastman Kodak Company

238 FDA decisions under this applicant name. See the company

  • K060550Kodak Directview DR 3000 System 64KW/80KW Generators, Models 6551345, 6551386Eastman Kodak Company · 20063 recalls
  • K060137Kodak Eclipse Image Processing SoftwareEastman Kodak Company · 2006
  • K060079Kodak Model CR-7400 Digital Radiography SystemEastman Kodak Company · 2006
  • K060055Kodak PacsEastman Kodak Company · 2006
  • K053347Kodak Carestream PacsEastman Kodak Company · 2006

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/K030781 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030781: Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak Directview CX/DX, Kodak Directvib.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030781

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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