510(k) Report

510(k) · Cleared

Cleared

Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray

K032638510(k) TraditionalCleared Sep 11, 200315-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

Planar Systems, Inc. · LLZ System, Image Processing, Radiological

Cleared on Sep 11, 2003 as substantially equivalent to K013922 (Barco N.V., 2002) after a 15-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.

Decided
Sep 11, 2003
Review
15 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K001753 (2000). 6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2004: 2 descendants cleared2014: 1 descendant cleared2012: 1 descendant clearedK001753 · Medis 5MP2 Dual-Head Medical Diagnostic Display System · Barco NV Display Systems · 2000K013922 · Coronis 3MP Medicl Flat Panel Display System · Barco N.V. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 1 descendant K013922 · Coronis 3MP Medicl Flat Panel Display System · Barco N.V. · 2002K001753 · Medis 5MP2 Dual-Head Medical Diagnostic Display System · Barco NV Display Systems · 20000
  1. Root · 2 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
  2. 1 generation backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
  3. This deviceK032638 Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 GrayPlanar Systems, Inc. · 2003
  4. Descendant · cites it directly · 1 of its ownK060136 Planar Dome EX Series Digital Flat-Panel Display System, Model E4C…Planar Systems, Inc. · 2006
  5. Descendant · cites it directly · 1 of its ownK040310 Nova Family of Medical Radiology DisplaysNational Display Systems · 2004
  6. Descendant · cites it directly · 0 of its ownK133609 The Dome S6CNds Surgical Imaging · 2014
  7. Descendant · 2 generations on · 0 of its ownK120709 The Dome GX4MP Color NonitorNds Surgical Imaging · 2012
  8. Descendant · cites it directly · 0 of its ownK053039 Clinton Electronics Series II Digital Grayscale Monitors, Models…Clinton Electronics Corp. · 2006

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004: 22006: 22012: 12014: 1
2004high 2 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all
  • K060136Planar Dome EX Series Digital Flat-Panel Display System, Model E4C ColorPlanar Systems, Inc. · 2006 · cites it directly1descendant
  • K040310Nova Family of Medical Radiology DisplaysNational Display Systems · 2004 · cites it directly1descendant
  • K133609The Dome S6CNds Surgical Imaging · 2014 · cites it directly0descendants
  • K120709The Dome GX4MP Color NonitorNds Surgical Imaging · 2012 · 2 generations on0descendants
  • K053039Clinton Electronics Series II Digital Grayscale Monitors, Models DL2000, DL3000, DL2000…Clinton Electronics Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K001753Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems2000—
−1K013922Coronis 3MP Medicl Flat Panel Display SystemBarco N.V.2002—
0 (this device)K032638Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 GrayPlanar Systems, Inc.2003—
+1K060136Planar Dome EX Series Digital Flat-Panel Display System, Model E4C ColorPlanar Systems, Inc.2006—
+1K040310Nova Family of Medical Radiology DisplaysNational Display Systems2004—
+1K133609The Dome S6CNds Surgical Imaging2014—
+2K120709The Dome GX4MP Color NonitorNds Surgical Imaging2012—
+1K053039Clinton Electronics Series II Digital Grayscale Monitors, Models DL2000…Clinton Electronics Corp.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200620
201210
201410
FIG. 1 — Lineage of K032638, 2000–2014Source: 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
*K013922Coronis 3MP Medicl Flat Panel Display SystemBarco N.V.2002—

Also cleared against K013922: 16 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K060136Planar Dome EX Series Digital Flat-Panel Display System, Model E4C ColorPlanar Systems, Inc.20061
K040310Nova Family of Medical Radiology DisplaysNational Display Systems20041
K133609The Dome S6CNds Surgical Imaging20140
K053039Clinton Electronics Series II Digital Grayscale Monitors, Models DL2000, DL3000, DL2000…Clinton Electronics Corp.20060
K042353Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome DisplaysNational Display Systems20040

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 3 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K060136 (Planar Systems, Inc., 2006) has gone furthest, with 1 descendant of its own.
  • 16 other devices also cite its predicate K013922.

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 DOME CXTMDIGITAL FLAT-PANEL DISPLAY SYSTEMTM, Models C3 Colorru and C3 GrayTu are intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.

Indications for use as stated in the FDA summary.

Also cleared against K013922

16 other devices cite the same predicate.

  • K073292MM/Mma/Color Series Digital Flat Panel Display SystemHeeyoung Co., Ltd. · 2008
  • K060136Planar Dome EX Series Digital Flat-Panel Display System, Model E4C ColorPlanar Systems, Inc. · 2006
  • K05294221.3INCH Monochrome LCD MonitorNec-Mitsubishi Electric Visual Systems Corp. · 2005
  • K052429Coronis 3MP-21 and MFGD 3621Barcoview · 2005
  • K042221Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
  • K042353Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome DisplaysNational Display Systems · 2004

More from Planar Systems, Inc.

4 FDA decisions under this applicant name. See the company

  • K061018Planar Dome EX Line Model Dome E2CPlanar Systems, Inc. · 2006
  • K060136Planar Dome EX Series Digital Flat-Panel Display System, Model E4C ColorPlanar Systems, Inc. · 2006
  • K032202Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003

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/K032638 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032638: Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032638

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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