510(k) Report

510(k) · Cleared

Cleared

Impax OT3000 Orthopedic Workstation

K040344510(k) TraditionalCleared May 12, 200490-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

Agfa Corp. · LLZ System, Image Processing, Radiological

Cleared on May 12, 2004 as substantially equivalent to K014113 (Siemens Medical Solutions USA, Inc., 2002) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.

Decided
May 12, 2004
Review
90 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K913475 (1991). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1999: 1 other ancestor2001: 2 other ancestors1998: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor2004: 1 descendant cleared2006: 1 descendant clearedK913475 · Magnetic Resonance Diagnostic Device · GE Medical Systems · 1991K960265 · Advantage Windows with Functool Option · GE Medical Systems · 1996 · recalledK971965 · Philips Easyvision · Philips Medical Systems, Inc. · 1998K022292 · Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho · Agfa Corp. · 2002 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K022292 · Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho · Agfa Corp. · 2002 · recalledK971965 · Philips Easyvision · Philips Medical Systems, Inc. · 1998K960265 · Advantage Windows with Functool Option · GE Medical Systems · 1996 · recalledK913475 · Magnetic Resonance Diagnostic Device · GE Medical Systems · 19910
  1. Root · 4 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
  2. 3 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
  3. 2 generations backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
  4. 1 generation backK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
  5. This deviceK040344 Impax OT3000 Orthopedic WorkstationAgfa Corp. · 2004
  6. Descendant · cites it directly · 1 of its ownK042867 Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc. · 2004
  7. Descendant · 2 generations on · 0 of its ownK060210 MediportMaxant Technologies, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all
  • K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc. · 2004 · cites it directly1descendant
  • K060210MediportMaxant Technologies, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K913475Magnetic Resonance Diagnostic DeviceGE Medical Systems1991—
−3K960265Advantage Windows with Functool OptionGE Medical Systems19961
−2K971965Philips EasyvisionPhilips Medical Systems, Inc.1998—
−1K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for…Agfa Corp.20029
0 (this device)K040344Impax OT3000 Orthopedic WorkstationAgfa Corp.2004—
+1K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc.2004—
+2K060210MediportMaxant Technologies, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199410
199810
199910
200120
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
FIG. 1 — Lineage of K040344, 1991–2006Source: 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? (3)

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
*K014113EndomapSiemens Medical Solutions USA, Inc.2002—
*K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…
Summary page 1
…valent to the Siemens' EndoMap (FDA Clearance ft K014l113; Clearance Date: 06/14/2002). The Diagnostic Workstation was previously submitted for FDA approval (K022292; Clearance Date: September 12, 2002) by Agfa Corporation and (K993532; Clearance Date: December 15, 1999) by Impax Technology.…
Agfa Corp.20029
*K993532DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (Amongst Other Names)
Summary page 1
…ate: 06/14/2002). The Diagnostic Workstation was previously submitted for FDA approval (K022292; Clearance Date: September 12, 2002) by Agfa Corporation and (K993532; Clearance Date: December 15, 1999) by Impax Technology. The workstation component is considered here in this submission for i…
Impax Technology, Inc.1999—

Also cleared against K014113: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042867Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc.20041

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 13 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
  • 2 of the 11 ancestors have a recall of any class.
  • Of its descendants, K042867 (Philips Medical Systems North America, Inc., 2004) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K014113.

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 Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to images acquired through the PACS system. These images can be utilized to place digital templates that reflect actual prosthetic implants…

Read the full statement (151 words)

The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment.

As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to images acquired through the PACS system. These images can be utilized to place digital templates that reflect actual prosthetic implants on patients' images helping the surgeon plan the surgical placement of the implant. These plans can be shown to patients to explain the procedure they will undergo and to help them understand the pathology present.

The application consists of the following components:

* Hip Prosthetic Planning

· Knee Prosthetic Planning

· Biometry Planning - takes into account patient motion and metrics

· Coxometry - tracking of known measurement values in pediatrics to determine surgical intervention

· Osteotomy - determines optimum osteotomy locations

* Impax Diagnostic Workstation

Indications for use as stated in the FDA summary.

Also cleared against K014113

1 other device cites the same predicate.

  • K050751Impax Orthopaedic Workstation, Model Impax ES 5.XAgfa Corp. · 20053 recalls

More from Agfa Corp.

19 FDA decisions under this applicant name. See the company

  • K063421DX-SIAgfa Corp. · 2006
  • K053458WEB1000Agfa Corp. · 20052 recalls
  • K050751Impax Orthopaedic Workstation, Model Impax ES 5.XAgfa Corp. · 20053 recalls
  • K050810Agfa CR50.0Agfa Corp. · 20052 recalls
  • K042779Radiotherapy Solution Based on CRAgfa Corp. · 2004

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/K040344 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040344: Impax OT3000 Orthopedic Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040344

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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