510(k) Report

510(k) · Cleared

Cleared

Nio 2MP Medical Flat Panel Display System

K042660510(k) TraditionalCleared Nov 19, 200452-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

Barco NV Barcoview · LLZ System, Image Processing, Radiological

Cleared on Nov 19, 2004 as substantially equivalent to K040039 (Barco N.V., 2004) after a 52-day review. Its family tree reaches back 3 generations to 2000. 8 later devices descend from it.

Decided
Nov 19, 2004
Review
52 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001753 (2000). 8 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2005: 4 descendants cleared2006: 3 descendants cleared2007: 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. · 2002K040039 · Nio 2MP Medical Grayscale Display System · Barco N.V. · 2004200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 3 descendants K040039 · Nio 2MP Medical Grayscale Display System · Barco N.V. · 2004K013922 · 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 · 3 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
  2. 2 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
  3. 1 generation backK040039 Nio 2MP Medical Grayscale Display SystemBarco N.V. · 2004
  4. This deviceK042660 Nio 2MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
  5. Descendant · cites it directly · 2 of its ownK052958 Color Nio 2MP, E-2320 CBarcoview · 2005
  6. Descendant · cites it directly · 1 of its ownK052276 Nio 2MP-20 and E-2620 SBarcoview · 2005
  7. Descendant · 2 generations on · 0 of its ownK070726 Nio Color 3MP and MDNC 3120Barcoview, Medical Imaging Systems · 2007
  8. Descendant · 2 generations on · 0 of its ownK062905 Nio Fusion 4MP; MDNC 4130Barcoview · 2006
  9. Descendant · cites it directly · 0 of its ownK053039 Clinton Electronics Series II Digital Grayscale Monitors, Models…Clinton Electronics Corp. · 2006

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005: 42006: 32007: 1
2005high 4 (2005) · low 0 (2008)2026

Most influential descendants

Showing 5 of 8 · See all
  • K052958Color Nio 2MP, E-2320 CBarcoview · 2005 · cites it directly2descendants
  • K052276Nio 2MP-20 and E-2620 SBarcoview · 2005 · cites it directly1descendant
  • K070726Nio Color 3MP and MDNC 3120Barcoview, Medical Imaging Systems · 2007 · 2 generations on0descendants
  • K062905Nio Fusion 4MP; MDNC 4130Barcoview · 2006 · 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
−3K001753Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems2000—
−2K013922Coronis 3MP Medicl Flat Panel Display SystemBarco N.V.2002—
−1K040039Nio 2MP Medical Grayscale Display SystemBarco N.V.2004—
0 (this device)K042660Nio 2MP Medical Flat Panel Display SystemBarco NV Barcoview2004—
+1K052958Color Nio 2MP, E-2320 CBarcoview2005—
+1K052276Nio 2MP-20 and E-2620 SBarcoview2005—
+2K070726Nio Color 3MP and MDNC 3120Barcoview, Medical Imaging Systems2007—
+2K062905Nio Fusion 4MP; MDNC 4130Barcoview2006—
+1K053039Clinton Electronics Series II Digital Grayscale Monitors, Models DL2000…Clinton Electronics Corp.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200540
200630
200710
FIG. 1 — Lineage of K042660, 2000–2007Source: 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? (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
*K040039Nio 2MP Medical Grayscale Display System
Summary page 1
…sification Number: 21 CFR 892.2050/Procode 9OLLZ Substantial Equivalence: Nio 2MP Medical Grayscale Display System (K040039) Device Description: The Nio 2MP device is a digital image display system Intende…
Barco N.V.2004—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K052958Color Nio 2MP, E-2320 CBarcoview20052
K052276Nio 2MP-20 and E-2620 SBarcoview20051
K053039Clinton Electronics Series II Digital Grayscale Monitors, Models DL2000, DL3000, DL2000…Clinton Electronics Corp.20060
K051901NIO 3MP-21Barcoview20050
K051201E1 Medical Flat Panel Display System and MFGD 1218 Medical Flat Panel DisplayBarcoview20050

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 3 companies; a new generation was cleared every 1.5 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K052958 (Barcoview, 2005) has gone furthest, with 2 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 Nio 2MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Indications for use as stated in the FDA summary.

More from Barco NV Barcoview

14 FDA decisions under this applicant name. See the company

  • K042221Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
  • K042662Nio 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
  • K042942MGP 15 Dicom TheaterBarco NV Barcoview · 2004
  • K042661Nio 3MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
  • K041508Barcoview Coronis 5MP HD Medical Flat Panel Display SystemBarco NV Barcoview · 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/K042660 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042660: Nio 2MP Medical Flat Panel Display System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042660

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