510(k) · Cleared
ClearedColor LCD Monitor, Flexscan MX300W
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 Dec 19, 2007 as substantially equivalent to K052344 (Eizo Nanao Corporation, 2005) after a 21-day review. Its family tree reaches back 2 generations to 2004. 6 later devices descend from it.
- Decided
- Dec 19, 2007
- 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). 6 later devices descend from it, 4 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 deviceK073340 Color LCD Monitor, Flexscan MX300WEizo Nanao Corporation · 2007
- Descendant · cites it directly · 2 of its ownK113226 8MP Color LCD Monitor,Radiforce RX840Eizo Nanao Corporation · 2011
- Descendant · 2 generations on · 1 of its ownK170949 RadiForce MX315WEizo Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK233465 RadiForce MX317WEizo Corporation · 2023
- Descendant · cites it directly · 0 of its ownK112466 4MP Color LCD Monitor, RADIFORCERX430Eizo Nanao Corporation · 2011
- Descendant · cites it directly · 0 of its ownK092741 Color LCD Monitor, Model Radiforce MX241WEizo Nanao Corporation · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K1132268MP Color LCD Monitor,Radiforce RX840Eizo Nanao Corporation · 2011 · cites it directly2descendants
- K170949RadiForce MX315WEizo Corporation · 2017 · 2 generations on1descendant
- K233465RadiForce MX317WEizo Corporation · 2023 · 3 generations on0descendants
- K1124664MP Color LCD Monitor, RADIFORCERX430Eizo Nanao Corporation · 2011 · cites it directly0descendants
- K092741Color LCD Monitor, Model Radiforce MX241WEizo Nanao Corporation · 2009 · cites it directly0descendants
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) | K073340 | Color LCD Monitor, Flexscan MX300W | Eizo Nanao Corporation | 2007 | — |
| +1 | K113226 | 8MP Color LCD Monitor,Radiforce RX840 | Eizo Nanao Corporation | 2011 | — |
| +2 | K170949 | RadiForce MX315W | Eizo Corporation | 2017 | — |
| +3 | K233465 | RadiForce MX317W | Eizo Corporation | 2023 | — |
| +1 | K112466 | 4MP Color LCD Monitor, RADIFORCERX430 | Eizo Nanao Corporation | 2011 | — |
| +1 | K092741 | Color LCD Monitor, Model Radiforce MX241W | Eizo Nanao Corporation | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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…. Predicate Device Manufacturer EIZO NANAO CORPORATION Device Name Color LCD Monitor Model Name RadiForce R31 510(k) No. K052344 8. Description of Device FlexScan MX300W is a 76cm (29.8") Color LCD display for medical image viewing and digital images vie… | 2005 |
What descends from it? (6)
4 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)
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 3 years and passes through 1 company; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113226 (Eizo Nanao Corporation, 2011) has gone furthest, with 2 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. 2007, 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?
FlexScan MX300W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MFI, etc. by trained medical practitioners. FlexScan MX30OW does not support the display of mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073340: Color LCD Monitor, Flexscan MX300W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073340
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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