510(k) · Cleared
ClearedPlanar Dome EX Series Digital Flat-Panel Display System, Model E4C Color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planar Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 31, 2006 as substantially equivalent to K013922 (Barco N.V., 2002) and 1 other predicate after a 12-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jan 31, 2006
- Review
- 12 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001753 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- 2 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- 1 generation backK032638 Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 GrayPlanar Systems, Inc. · 2003
- This deviceK060136 Planar Dome EX Series Digital Flat-Panel Display System, Model E4C…Planar Systems, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK120709 The Dome GX4MP Color NonitorNds Surgical Imaging · 2012
Most influential descendants
Showing 1 of 1 · See all- K120709The Dome GX4MP Color NonitorNds Surgical Imaging · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| −2 | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| −1 | K032638 | Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray | Planar Systems, Inc. | 2003 | — |
| 0 (this device) | K060136 | Planar Dome EX Series Digital Flat-Panel Display System, Model E4C Color | Planar Systems, Inc. | 2006 | — |
| +1 | K120709 | The Dome GX4MP Color Nonitor | Nds Surgical Imaging | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013922 | Coronis 3MP Medicl Flat Panel Display SystemSummary page 2…ls E4c ColorTM is substantially equivalent to the BARCO NV, CORONIS 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM TM (K013922) and the Planar DOME CXTM DIGITAL FLAT-PANEL DISPLAY SYSTEM TM , Models C3 Color TM and C3 Gray 'M… | 2002 |
| * | K032638 | Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 GraySummary page 1…BARCO NV, CORONIS 3MP MEDICAL FLAT PANEL DISPLAY SYSTEMT M And 510(k) Number: K032638 Decision Date: 09/11/2003 Planar DOME CX TM DIGITAL FLAT-PANEL DISPLA… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120709 | The Dome GX4MP Color Nonitor | 2012 | 0 |
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 6 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120709 (Nds Surgical Imaging, 2012) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K013922.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The Planar DOME DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model E4c is intended to be used in displaying and viewing medical images for review and analysis by trained medical practitioners.
This device must not be used in primary image diagnosis in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060136 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060136: Planar Dome EX Series Digital Flat-Panel Display System, Model E4C Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060136
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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