510(k) · Cleared
ClearedMonochrome LCD Monitor, Radiforce Model GS310
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 Apr 25, 2006 as substantially equivalent to K052337 (Eizo Nanao Corporation, 2005) after a 28-day review. Its family tree reaches back 4 generations to 2000. 13 later devices descend from it.
- Decided
- Apr 25, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000293 (2000). 13 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 3 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 2 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 1 generation backK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
- This deviceK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006
- Descendant · cites it directly · 11 of its ownK062053 Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006
- Descendant · 2 generations on · 8 of its ownK113784 3MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012
- Descendant · 3 generations on · 4 of its ownK201211 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors…Shenzhen Beacon Display Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 2 of its ownK141690 Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014
- Descendant · 4 generations on · 1 of its ownK240310 LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. · 2024
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K062053Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006 · cites it directly11descendants
- K1137843MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012 · 2 generations on8descendants
- K2012113MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+Shenzhen Beacon Display Technology Co., Ltd. · 2020 · 3 generations on4descendants
- K141690Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014 · 3 generations on2descendants
- K240310LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −3 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −2 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −1 | K052337 | Monochrome LCD Monitor, Model Radiforce G33 | Eizo Nanao Corporation | 2005 | — |
| 0 (this device) | K060845 | Monochrome LCD Monitor, Radiforce Model GS310 | Eizo Nanao Corporation | 2006 | — |
| +1 | K062053 | Monochrome LCD Monitor, Radiforce, GS320 | Eizo Nanao Corporation | 2006 | — |
| +2 | K113784 | 3MP Monochrome LCD Monitor, Radiforce GX340 | Eizo Nanao Corporation | 2012 | — |
| +3 | K201211 | 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ | Shenzhen Beacon Display Technology Co., Ltd. | 2020 | — |
| +3 | K141690 | Jusha-M33C LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. | 2014 | — |
| +4 | K240310 | LCD Monitors C310S, G310S, C316S, G316S, C616W | Shenzhen Beacon Display Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 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 |
|---|---|---|---|
| * | K052337 | Monochrome LCD Monitor, Model Radiforce G33Summary page 1…icate Device Manufacturer : EIZO NANAO CORPORATION Device Name : Monochrome LCD Monitor Model Name : RadiiForce 033 5 10(k) No. : K052337 8. Description of Device RadiForce GS310 is a 53cm (20.8") Monochrome LCD display for medical image viewing. GS310 display… | 2005 |
What descends from it? (13)
See all 132 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 6 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K062053 (Eizo Nanao Corporation, 2006) has gone furthest, with 11 descendants of its own.
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 GS310 is intended to be used in displaying and viewing digital images for
diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified
for digital mammography system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060845 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060845: Monochrome LCD Monitor, Radiforce Model GS310.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060845
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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