510(k) · Cleared
ClearedColor LCD Monitor, Radiforce RX320
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eizo Nanao Corporation · LLZ System, Image Processing, Radiological
Cleared on Jan 28, 2009 as substantially equivalent to K052344 (Eizo Nanao Corporation, 2005) after a 21-day review. Its family tree reaches back 2 generations to 2004. 35 later devices descend from it.
- Decided
- Jan 28, 2009
- Review
- 21 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033466 (2004). 35 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
- 1 generation backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
- This deviceK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
- Descendant · cites it directly · 34 of its ownK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
- Descendant · 2 generations on · 17 of its ownK153354 3MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016
- Descendant · 2 generations on · 14 of its ownK134002 6MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · Recalled
- Descendant · 3 generations on · 7 of its ownK182591 RadiForce RX360, RX360-AREizo Corporation · 2018 · Recalled
- Descendant · 3 generations on · 5 of its ownK191864 21HK512DLg Electronics.Inc · 2019
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K1135623MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012 · cites it directly34descendants
- K1533543MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016 · 2 generations on17descendants
- K1340026MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · 2 generations on14descendants
- K182591RadiForce RX360, RX360-AREizo Corporation · 2018 · 3 generations on7descendants
- K19186421HK512DLg Electronics.Inc · 2019 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033466 | Color LCD Display, Model Radiforce R22 | Eizo Nanao Corporation | 2004 | — |
| −1 | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-C | Eizo Nanao Corporation | 2005 | — |
| 0 (this device) | K090045 | Color LCD Monitor, Radiforce RX320 | Eizo Nanao Corporation | 2009 | — |
| +1 | K113562 | 3MP Color LCD Monitor, Radiforce RX340 | Eizo Nanao Corporation | 2012 | — |
| +2 | K153354 | 3MP Color LCD Monitor, RadiForce RX350 | Eizo Corporation | 2016 | — |
| +2 | K134002 | 6MP Color LCD Monitor, Radiforce RX650 | Eizo Corporation | 2014 | 1 |
| +3 | K182591 | RadiForce RX360, RX360-AR | Eizo Corporation | 2018 | 1 |
| +3 | K191864 | 21HK512D | Lg Electronics.Inc | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K052344 | Color LCD Monitor, Model Radioforce R31 & R31-CSummary page 1…e Device Manufacturer : EIZO NANAO CORPORATION Device Name : Color LCD Monitor Model Name : RadiForce R31 and R31-C 510(k) No. : K052344 8. Description of Device RadiForce RX320 is a 54cm (21.2") Color LCD display for medical image viewing. RX320 dis… | 2005 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113562 | 3MP Color LCD Monitor, Radiforce RX340 | 2012 | 34 |
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 5 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113562 (Eizo Nanao Corporation, 2012) has gone furthest, with 34 descendants of its own.
- 3 other devices also cite its predicate K052344.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
RadiForce RX320 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. RadiForce RX320 does not support the display of mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090045: Color LCD Monitor, Radiforce RX320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090045
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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