510(k) · Cleared
ClearedLumimed Monochrome LCD Monitor, Models MM 20, MM 30 and MM50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heeyoung Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Dec 16, 2005 as substantially equivalent to K042755 (Eizo Nanao Corporation, 2005) after a 134-day review. Its family tree reaches back 6 generations to 1991. 2 later devices descend from it.
- Decided
- Dec 16, 2005
- Review
- 134 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). 2 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 deviceK052120 Lumimed Monochrome LCD Monitor, Models MM 20, MM 30 and MM50Heeyoung Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK123944 Kostec Medical Grade LDC MonitorsKostec Co., Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK072532 Truepix LCD Medical Display Monitor, Models TX-5M, TX-3M, TX-2MDooyang Systems, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView 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) | K052120 | Lumimed Monochrome LCD Monitor, Models MM 20, MM 30 and MM50 | Heeyoung Co., Ltd. | 2005 | — |
| +1 | K123944 | Kostec Medical Grade LDC Monitors | Kostec Co., Ltd. | 2013 | — |
| +1 | K072532 | Truepix LCD Medical Display Monitor, Models TX-5M, TX-3M, TX-2M | Dooyang Systems, Inc. | 2007 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 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…Monitor Monochrome LCD 2. Equivalent legally marketed devices: RadiForce 051, 5 Megapixel Monitor (K042755, EIZO NANAO Corp.) to be used in 3. Indications for… | 2005 |
What descends from it? (2)
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 14 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K123944 (Kostec Co., Ltd., 2013) has gone furthest, with 0 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?
Monochrome LCD Monitors intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance requirements specified by the manufacturer of the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052120: Lumimed Monochrome LCD Monitor, Models MM 20, MM 30 and MM50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052120
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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