510(k) · Cleared
Cleared5 Megapixel Monochrome LCD Monitor, Model Radiforce GS520
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 Mar 10, 2008 as substantially equivalent to K062054 (Eizo Nanao Corporation, 2006) after a 24-day review. Its family tree reaches back 7 generations to 1991. 1 later device descends from it.
- Decided
- Mar 10, 2008
- Review
- 24 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). 1 later device descends 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 deviceK080422 5 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation · 2008
- Descendant · cites it directly · 0 of its ownK101796 Pacsmate MMD-5201M MonitorIei Technology Corp. · 2010
Most influential descendants
Showing 1 of 1 · See all- K101796Pacsmate MMD-5201M MonitorIei Technology Corp. · 2010 · cites it directly0descendants
View 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) | K080422 | 5 Megapixel Monochrome LCD Monitor, Model Radiforce GS520 | Eizo Nanao Corporation | 2008 | — |
| +1 | K101796 | Pacsmate MMD-5201M Monitor | Iei Technology Corp. | 2010 | — |
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 |
|---|---|---|
| 2010 | 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…Device Manufacturer :EIZO NANAO CORPORATION Device Name :5 Megapixel Monochrome LCD Monitor Model Name :RadiForce GS51O * 51 0(k) No. :K062054 8. Description of Device RadiForce GS520 device is a digital image display. G520 displays high-definition (5 Megap… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101796 | Pacsmate MMD-5201M Monitor | 2010 | 0 |
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 17 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, K101796 (Iei Technology Corp., 2010) has gone furthest, with 0 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. 2008, 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 GS520 is intended to be used in various kinds of medical image applications
including digital mammography system for which the device complies with performance
specified by the manufacture of the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080422 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080422: 5 Megapixel Monochrome LCD Monitor, Model Radiforce GS520.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080422
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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