510(k) · Cleared
ClearedFlat Panel Display, ME183L
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 as substantially equivalent to K012099 (Totoku Electric Co., Ltd., 2001) after an 88-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Apr 25, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000293 (2000). 6 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 1 generation backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- This deviceK030272 Flat Panel Display, ME183LTotoku Electric Co., Ltd. · 2003
- Descendant · cites it directly · 3 of its ownK051403 19-Inch (48CM) Color LCD Monitor CDL1904ATotoku Electric Co., Ltd. · 2005
- Descendant · 2 generations on · 1 of its ownK060961 15-Inch (38CM) Color LCD Monitor CDL1566ATotoku Electric Co., Ltd. · 2006
- Descendant · 2 generations on · 0 of its ownK080951 19-Inch (48CM) 1.3M Color LCD Monitor CDL1909ATotoku Electric Co., Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK080952 15-Inch (38 CM) Color LCD Monitor CDL1576ATotoku Electric Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK072066 1.3M Monochrome LCD Monitor MDL1908ATotoku Electric Co., Ltd. · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K05140319-Inch (48CM) Color LCD Monitor CDL1904ATotoku Electric Co., Ltd. · 2005 · cites it directly3descendants
- K06096115-Inch (38CM) Color LCD Monitor CDL1566ATotoku Electric Co., Ltd. · 2006 · 2 generations on1descendant
- K08095119-Inch (48CM) 1.3M Color LCD Monitor CDL1909ATotoku Electric Co., Ltd. · 2008 · 2 generations on0descendants
- K08095215-Inch (38 CM) Color LCD Monitor CDL1576ATotoku Electric Co., Ltd. · 2008 · 3 generations on0descendants
- K0720661.3M Monochrome LCD Monitor MDL1908ATotoku Electric Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −1 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| 0 (this device) | K030272 | Flat Panel Display, ME183L | Totoku Electric Co., Ltd. | 2003 | — |
| +1 | K051403 | 19-Inch (48CM) Color LCD Monitor CDL1904A | Totoku Electric Co., Ltd. | 2005 | — |
| +2 | K060961 | 15-Inch (38CM) Color LCD Monitor CDL1566A | Totoku Electric Co., Ltd. | 2006 | — |
| +2 | K080951 | 19-Inch (48CM) 1.3M Color LCD Monitor CDL1909A | Totoku Electric Co., Ltd. | 2008 | — |
| +3 | K080952 | 15-Inch (38 CM) Color LCD Monitor CDL1576A | Totoku Electric Co., Ltd. | 2008 | — |
| +1 | K072066 | 1.3M Monochrome LCD Monitor MDL1908A | Totoku Electric Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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 21.6 · 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 |
|---|---|---|---|
| * | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | 2001 |
What descends from it? (6)
3 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 3 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051403 (Totoku Electric Co., Ltd., 2005) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K012099.
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?
ME183L Medical Display is intended for use with Picture Archiving Communication Systems (PACS)
for medical imaging application by physicians.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K030272 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030272: Flat Panel Display, ME183L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030272
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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