510(k) · Cleared
ClearedDome CX Digital Flat-Panel Display System, Model C5I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dome Imaging Systems, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jun 16, 2004 as substantially equivalent to K032202 (Planar Systems, Inc., 2003) after a 117-day review. Its family tree reaches back 4 generations to 2000. 7 later devices descend from it.
- Decided
- Jun 16, 2004
- Review
- 117 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001753 (2000). 5 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- 3 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- 2 generations backK023341 Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002
- 1 generation backK032202 Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003
- This deviceK040443 Dome CX Digital Flat-Panel Display System, Model C5IDome Imaging Systems, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK042221 Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
- Descendant · 2 generations on · 2 of its ownK062131 Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BBBarcoview · 2006
- Descendant · 2 generations on · 1 of its ownK062621 Nio 5MP-21 and MDNG-5121 CBBarcoview · 2007
- Descendant · 3 generations on · 0 of its ownK160347 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21Qingdao Hisense Medical Equipment Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK132610 5MP Grayscale LCD DisplayShenzhen Beacon Display Technology Co., Ltd. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K042221Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004 · cites it directly6descendants
- K062131Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BBBarcoview · 2006 · 2 generations on2descendants
- K062621Nio 5MP-21 and MDNG-5121 CBBarcoview · 2007 · 2 generations on1descendant
- K160347Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21Qingdao Hisense Medical Equipment Co., Ltd. · 2016 · 3 generations on0descendants
- K1326105MP Grayscale LCD DisplayShenzhen Beacon Display Technology Co., Ltd. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| −3 | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| −2 | K023341 | Cornis 5MP Medical Flat Panel Display System | Barco N.V. | 2002 | — |
| −1 | K032202 | Dome CX Digital Flat-Panel Display System, Models C2 and C5I | Planar Systems, Inc. | 2003 | — |
| 0 (this device) | K040443 | Dome CX Digital Flat-Panel Display System, Model C5I | Dome Imaging Systems, Inc. | 2004 | — |
| +1 | K042221 | Coronis 5MP Medical Flat Panel Display System | Barco NV Barcoview | 2004 | — |
| +2 | K062131 | Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB | Barcoview | 2006 | — |
| +2 | K062621 | Nio 5MP-21 and MDNG-5121 CB | Barcoview | 2007 | — |
| +3 | K160347 | Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 | Qingdao Hisense Medical Equipment Co., Ltd. | 2016 | — |
| +3 | K132610 | 5MP Grayscale LCD Display | Shenzhen Beacon Display Technology Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032202 | Dome CX Digital Flat-Panel Display System, Models C2 and C5ISummary page 1…PROCESSING, Name RADIOLOGICAL Regulation Number 892.2050 510(k) Number K032202 DOME CXTm DIGITAL FLAT-… | 2003 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042221 | Coronis 5MP Medical Flat Panel Display System | 2004 | 6 |
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 5 ancestors has a recall.
- Of its descendants, K042221 (Barco NV Barcoview, 2004) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K032202.
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 DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, Model C5i is intended to be used in displaying and viewing radiographs of the breast for review and analysis by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040443 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040443: Dome CX Digital Flat-Panel Display System, Model C5I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040443
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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