510(k) · Cleared
Cleared5MP Monochrome LCD Monitor, Radiforce GX530
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 Nov 30, 2011 as substantially equivalent to K062054 (Eizo Nanao Corporation, 2006) after a 106-day review. Its family tree reaches back 7 generations to 1991. 3 later devices descend from it.
- Decided
- Nov 30, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 19 ancestors in all, the oldest K885042 (1988). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
- 4 generations backK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
- 3 generations backK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
- 2 generations backK042755 Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005
- 1 generation backK062054 5 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation · 2006
- This deviceK112354 5MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation · 2011
- Descendant · cites it directly · 2 of its ownK120451 8MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK143718 Mammography Color Display DP-M3010Canon, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK140702 8MP Color LCD Monitor, Radiforce RX850Eizo Corporation · 2014 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K972701 | Barco MWD 321 Medical Workstation Display | Barco NV Display Systems | 1998 | — |
| −4 | K980541 | Barco MGD 521 5 Megapixel Diagnostic Display | Barco NV Display Systems | 1998 | — |
| −3 | K033859 | Barcoview MGD 521M Digital Mammography Display | Barco NV Barcoview | 2004 | — |
| −2 | K042755 | Monochrome LCD Monitor, Radiforce G51 | Eizo Nanao Corporation | 2005 | — |
| −1 | K062054 | 5 Megapixel Monochrome LCD Monitor, Radiforce GS510 | Eizo Nanao Corporation | 2006 | — |
| 0 (this device) | K112354 | 5MP Monochrome LCD Monitor, Radiforce GX530 | Eizo Nanao Corporation | 2011 | — |
| +1 | K120451 | 8MP Color LCD Monitor, Rediforce RX840 | Eizo Nanao Corporation | 2012 | — |
| +2 | K143718 | Mammography Color Display DP-M3010 | Canon, Inc. | 2015 | — |
| +2 | K140702 | 8MP Color LCD Monitor, Radiforce RX850 | Eizo Corporation | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K062054 | 5 Megapixel Monochrome LCD Monitor, Radiforce GS510Summary page 1…sing, Radiological * Classification Number: 21 CFR 892.2050, Product Code LLZ 5. Predicate Device SMP Monochrome LCD Monitor, RadiForce GS5 10 (K062054) 6. Device Description The RadiForce GX530 is a 5MP monochrome LCD monitor for viewing medical images including those of digital… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120451 | 8MP Color LCD Monitor, Rediforce RX840 | 2012 | 2 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K120451 (Eizo Nanao Corporation, 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K062054.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The RadiForce GX530 is intended to be used in displaying and viewing digital images including
those of digital mammography for review and analysis by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112354: 5MP Monochrome LCD Monitor, Radiforce GX530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112354
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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