510(k) Report

510(k) · Cleared

Cleared

Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome Displays

K042353510(k) TraditionalCleared Nov 24, 200486-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

National Display Systems · LLZ System, Image Processing, Radiological

Cleared on Nov 24, 2004 as substantially equivalent to K040310 (National Display Systems, 2004) and 6 other predicates after an 86-day review. Its family tree reaches back 5 generations to 2000.

Decided
Nov 24, 2004
Review
86 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
7

Its longest line of descent runs back 5 generations to K001753 (2000). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 2 other ancestorsK001753 · Medis 5MP2 Dual-Head Medical Diagnostic Display System · Barco NV Display Systems · 2000K013922 · Coronis 3MP Medicl Flat Panel Display System · Barco N.V. · 2002K023341 · Cornis 5MP Medical Flat Panel Display System · Barco N.V. · 2002K032202 · Dome CX Digital Flat-Panel Display System, Models C2 and C5I · Planar Systems, Inc. · 2003K040310 · Nova Family of Medical Radiology Displays · National Display Systems · 20042000200220042006
Other ancestors, by generation 1 generation back: 3 other ancestors K040310 · Nova Family of Medical Radiology Displays · National Display Systems · 2004K032202 · Dome CX Digital Flat-Panel Display System, Models C2 and C5I · Planar Systems, Inc. · 2003K023341 · Cornis 5MP Medical Flat Panel Display System · Barco N.V. · 2002K013922 · Coronis 3MP Medicl Flat Panel Display System · Barco N.V. · 2002K001753 · Medis 5MP2 Dual-Head Medical Diagnostic Display System · Barco NV Display Systems · 2000−50
  1. Root · 5 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
  2. 4 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
  3. 3 generations backK023341 Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002
  4. 2 generations backK032202 Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003
  5. 1 generation backK040310 Nova Family of Medical Radiology DisplaysNational Display Systems · 2004
  6. This deviceK042353 Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome DisplaysNational Display Systems · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K001753Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems2000—
−4K013922Coronis 3MP Medicl Flat Panel Display SystemBarco N.V.2002—
−3K023341Cornis 5MP Medical Flat Panel Display SystemBarco N.V.2002—
−2K032202Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc.2003—
−1K040310Nova Family of Medical Radiology DisplaysNational Display Systems2004—
0 (this device)K042353Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome DisplaysNational Display Systems2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200220
200310
FIG. 1 — Lineage of K042353, 2000–2004Source: 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? (7)

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
*K040310Nova Family of Medical Radiology Displays
Summary page 1
…AXIS V Monochrome Display (5MP) H. Classification Number: 21 CFR 892.2050/Procode 9OLLZ I. Substantial Equivalence: AXIS I (IMP) = Nova IMP (NDS) K040310 and Coronis IMP (Barco) K023340 AXIS II (2MP) = Nova 2MP (NDS) K0403 10; Coronis 2MP (Barco) K023322 and Dome C…
National Display Systems2004—
*K023340Coronis 1MP Medical Flat Panel Display System
Summary page 1
…Display (5MP) H. Classification Number: 21 CFR 892.2050/Procode 9OLLZ I. Substantial Equivalence: AXIS I (IMP) = Nova IMP (NDS) K040310 and Coronis IMP (Barco) K023340 AXIS II (2MP) = Nova 2MP (NDS) K0403 10; Coronis 2MP (Barco) K023322 and Dome C2 (Planar Systems) K(032202 AXIS…
Barco N.V.2002—
*K023322Coronis 2MP Medical Flat Panel Display System
Summary page 1
…9OLLZ I. Substantial Equivalence: AXIS I (IMP) = Nova IMP (NDS) K040310 and Coronis IMP (Barco) K023340 AXIS II (2MP) = Nova 2MP (NDS) K0403 10; Coronis 2MP (Barco) K023322 and Dome C2 (Planar Systems) K(032202 AXIS III (3MP) = Nova 3MP (NDS) K0403 10; Coronis 3MP (Barco) KO(013922 an…
Barco N.V.2002—
*K032202Dome CX Digital Flat-Panel Display System, Models C2 and C5I
Summary page 1
…a IMP (NDS) K040310 and Coronis IMP (Barco) K023340 AXIS II (2MP) = Nova 2MP (NDS) K0403 10; Coronis 2MP (Barco) K023322 and Dome C2 (Planar Systems) K(032202 AXIS III (3MP) = Nova 3MP (NDS) K0403 10; Coronis 3MP (Barco) KO(013922 and Dome C3 (Planar Systems) K032638 AXI…
Planar Systems, Inc.2003—
*K013922Coronis 3MP Medicl Flat Panel Display System
Summary page 1
…a 2MP (NDS) K0403 10; Coronis 2MP (Barco) K023322 and Dome C2 (Planar Systems) K(032202 AXIS III (3MP) = Nova 3MP (NDS) K0403 10; Coronis 3MP (Barco) KO(013922 and Dome C3 (Planar Systems) K032638 AXIS V (5NIP) = Nova 5MP (NDS) K(0403 10; Coronis 5MP (Barco) K(023341 and…
Barco N.V.2002—
*K032638Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray
Summary page 1
…Dome C2 (Planar Systems) K(032202 AXIS III (3MP) = Nova 3MP (NDS) K0403 10; Coronis 3MP (Barco) KO(013922 and Dome C3 (Planar Systems) K032638 AXIS V (5NIP) = Nova 5MP (NDS) K(0403 10; Coronis 5MP (Barco) K(023341 and Dome C5i (Planar Systems) K(032202 J…
Planar Systems, Inc.2003—
*K023341Cornis 5MP Medical Flat Panel Display System
Summary page 1
…a 3MP (NDS) K0403 10; Coronis 3MP (Barco) KO(013922 and Dome C3 (Planar Systems) K032638 AXIS V (5NIP) = Nova 5MP (NDS) K(0403 10; Coronis 5MP (Barco) K(023341 and Dome C5i (Planar Systems) K(032202 J. Device Description: The AXIS Monochrome Display is a diagnosti…
Barco N.V.2002—

What descends from it?

No later submission names this one as a predicate yet.

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 11 months on median.
  • None of the 8 ancestors has a recall.

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 AXIS Radiology Monochrome Medical Displays are intended to be used to display and

view digital images for review and analysis by trained medical practitioners. The AXIS 5MP display

is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The

AXIS IMP, 2MP and 3MP displays are not intended for use with FFDM.

Indications for use as stated in the FDA summary.

More from National Display Systems

3 FDA decisions under this applicant name. See the company

  • K063066Axis-V Monochrome 5 MP DisplayNational Display Systems · 2007
  • K040310Nova Family of Medical Radiology DisplaysNational Display Systems · 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/K042353 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042353: Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome Displays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042353

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