510(k) · Cleared
Recalled · Class II · 20156MP Color LCD Monitor, Radiforce RX650
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eizo Corporation · LLZ System, Image Processing, Radiological
Cleared on Jan 31, 2014 as substantially equivalent to K113562 (Eizo Nanao Corporation, 2012) after a 35-day review. Its family tree reaches back 4 generations to 2004. 14 later devices descend from it. It has been recalled once.
- Decided
- Jan 31, 2014
- Review
- 35 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K033466 (2004). 14 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 3 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- 2 generations backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- 1 generation backK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- This deviceK134002 6MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014
- Descendant · cites it directly · 5 of its ownK141679 Jusha-C61 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014
- Descendant · cites it directly · 3 of its ownK163335 6MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation · 2016
- Descendant · 2 generations on · 2 of its ownK183492 JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor…Nanjing Jusha Display Technology Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK182291 6MP Color LCD Monitor (C61W+)Shenzhen Beacon Display Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK240310 LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K141679Jusha-C61 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014 · cites it directly5descendants
- K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation · 2016 · cites it directly3descendants
- K183492JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2019 · 2 generations on2descendants
- K1822916MP Color LCD Monitor (C61W+)Shenzhen Beacon Display Technology Co., Ltd. · 2018 · cites it directly2descendants
- K240310LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −3 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| −2 | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| −1 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| 0 (this device) | K134002 | 6MP Color LCD Monitor, Radiforce RX650 | Eizo Corporation | 2014 | — |
| +1 | K141679 | Jusha-C61 LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2014 | — |
| +1 | K163335 | 6MP Color LCD Monitor, RadiForce RX660, RX660-AR | Eizo Corporation | 2016 | — |
| +2 | K183492 | JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD… | Nanjing Jusha Display Technology Co., Ltd. | 2019 | — |
| +1 | K182291 | 6MP Color LCD Monitor (C61W+) | Shenzhen Beacon Display Technology Co., Ltd. | 2018 | — |
| +2 | K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | 2012 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2015 | Class II | Z-2088-2015 | Device Design | EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K141679 (Nanjing Jusha Display Technology Co., Ltd., 2014) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K113562.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K134002: 6MP Color LCD Monitor, Radiforce RX650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K134002
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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