510(k) · Cleared
ClearedMedical Flat Panel Display, ME315L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Totoku Electric Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 25, 2003 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 25, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK030274 Medical Flat Panel Display, ME315LTotoku Electric Co., Ltd. · 2003
- Descendant · cites it directly · 3 of its ownK050485 20.8-Inch (53CM) Monochrome LCD Monitor MDL2110A (ME351I), (DV3MM-HB)Totoku Electric Co., Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK063197 21.3 Inch (54CM) Monochrome LCD Monitor MDL2118A (ME355I2)Totoku Electric Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK060210 MediportMaxant Technologies, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK052199 21.3-Inch (54 CM) Monochrome LCD Monitor MDL2115A (ME353I)…Totoku Electric Co., Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK031661 5M Medical Flat Panel Display, ME511LTotoku Electric Co., Ltd. · 2004
Most influential descendants
Showing 5 of 5 · See all- K05048520.8-Inch (53CM) Monochrome LCD Monitor MDL2110A (ME351I), (DV3MM-HB)Totoku Electric Co., Ltd. · 2005 · cites it directly3descendants
- K06319721.3 Inch (54CM) Monochrome LCD Monitor MDL2118A (ME355I2)Totoku Electric Co., Ltd. · 2006 · 2 generations on0descendants
- K060210MediportMaxant Technologies, Inc. · 2006 · 2 generations on0descendants
- K05219921.3-Inch (54 CM) Monochrome LCD Monitor MDL2115A (ME353I), (DV3MM-HB), (ME353IM)Totoku Electric Co., Ltd. · 2005 · 2 generations on0descendants
- K0316615M Medical Flat Panel Display, ME511LTotoku Electric Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030274 | Medical Flat Panel Display, ME315L | Totoku Electric Co., Ltd. | 2003 | — |
| +1 | K050485 | 20.8-Inch (53CM) Monochrome LCD Monitor MDL2110A (ME351I), (DV3MM-HB) | Totoku Electric Co., Ltd. | 2005 | — |
| +2 | K063197 | 21.3 Inch (54CM) Monochrome LCD Monitor MDL2118A (ME355I2) | Totoku Electric Co., Ltd. | 2006 | — |
| +2 | K060210 | Mediport | Maxant Technologies, Inc. | 2006 | — |
| +2 | K052199 | 21.3-Inch (54 CM) Monochrome LCD Monitor MDL2115A (ME353I), (DV3MM-HB)… | Totoku Electric Co., Ltd. | 2005 | — |
| +1 | K031661 | 5M Medical Flat Panel Display, ME511L | Totoku Electric Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
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?
- Of its descendants, K050485 (Totoku Electric Co., Ltd., 2005) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K030274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030274: Medical Flat Panel Display, ME315L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030274
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026