510(k) · Cleared
Cleared5 Megapixel Monochrome LCD Monitor, Radiforce GS510
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 Oct 6, 2006 as substantially equivalent to K042755 (Eizo Nanao Corporation, 2005) after a 78-day review. Its family tree reaches back 6 generations to 1991. 6 later devices descend from it.
- Decided
- Oct 6, 2006
- Review
- 78 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913770 (1991). 18 ancestors in all, the oldest K885042 (1988). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
- 3 generations backK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
- 2 generations backK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
- 1 generation backK042755 Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005
- This deviceK062054 5 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation · 2006
- Descendant · cites it directly · 3 of its ownK112354 5MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation · 2011
- Descendant · 2 generations on · 2 of its ownK120451 8MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation · 2012
- Descendant · cites it directly · 1 of its ownK080422 5 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation · 2008
- Descendant · 3 generations on · 0 of its ownK143718 Mammography Color Display DP-M3010Canon, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK140702 8MP Color LCD Monitor, Radiforce RX850Eizo Corporation · 2014 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K1123545MP Monochrome LCD Monitor, Radiforce GX530Eizo Nanao Corporation · 2011 · cites it directly3descendants
- K1204518MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation · 2012 · 2 generations on2descendants
- K0804225 Megapixel Monochrome LCD Monitor, Model Radiforce GS520Eizo Nanao Corporation · 2008 · cites it directly1descendant
- K143718Mammography Color Display DP-M3010Canon, Inc. · 2015 · 3 generations on0descendants
- K1407028MP Color LCD Monitor, Radiforce RX850Eizo Corporation · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K972701 | Barco MWD 321 Medical Workstation Display | Barco NV Display Systems | 1998 | — |
| −3 | K980541 | Barco MGD 521 5 Megapixel Diagnostic Display | Barco NV Display Systems | 1998 | — |
| −2 | K033859 | Barcoview MGD 521M Digital Mammography Display | Barco NV Barcoview | 2004 | — |
| −1 | K042755 | Monochrome LCD Monitor, Radiforce G51 | Eizo Nanao Corporation | 2005 | — |
| 0 (this device) | K062054 | 5 Megapixel Monochrome LCD Monitor, Radiforce GS510 | Eizo Nanao Corporation | 2006 | — |
| +1 | K112354 | 5MP Monochrome LCD Monitor, Radiforce GX530 | Eizo Nanao Corporation | 2011 | — |
| +2 | K120451 | 8MP Color LCD Monitor, Rediforce RX840 | Eizo Nanao Corporation | 2012 | — |
| +1 | K080422 | 5 Megapixel Monochrome LCD Monitor, Model Radiforce GS520 | Eizo Nanao Corporation | 2008 | — |
| +3 | K143718 | Mammography Color Display DP-M3010 | Canon, Inc. | 2015 | — |
| +3 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K042755 | Monochrome LCD Monitor, Radiforce G51Summary page 1…e Manufacturer EIZO NANAO CORPORATION Device Name 5 Megapixel Monochrome LCD Monitor Model Name RadiForce G51 510(k) No. K042755 8. Description of Device RadiForce GS510 device is a digital image display. G51 displays high-definition (5 Megapixel)… | 2005 |
What descends from it? (6)
2 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 15 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K112354 (Eizo Nanao Corporation, 2011) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K042755.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 GS510 is intended to be used in various kinds of medical image applications including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062054: 5 Megapixel Monochrome LCD Monitor, Radiforce GS510.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062054
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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