510(k) · Cleared
Cleared21.3-Inch (54 CM) Monochrome LCD Monitor MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
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 Sep 22, 2005 as substantially equivalent to K050485 (Totoku Electric Co., Ltd., 2005) after a 41-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Sep 22, 2005
- Review
- 41 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030274 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK030274 Medical Flat Panel Display, ME315LTotoku Electric Co., Ltd. · 2003
- 1 generation backK050485 20.8-Inch (53CM) Monochrome LCD Monitor MDL2110A (ME351I), (DV3MM-HB)Totoku Electric Co., Ltd. · 2005
- This deviceK052199 21.3-Inch (54 CM) Monochrome LCD Monitor MDL2115A (ME353I)…Totoku Electric Co., Ltd. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K052199 | 21.3-Inch (54 CM) Monochrome LCD Monitor MDL2115A (ME353I), (DV3MM-HB)… | Totoku Electric Co., Ltd. | 2005 | — |
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 |
|---|---|---|---|
| * | K050485 | 20.8-Inch (53CM) Monochrome LCD Monitor MDL2110A (ME351I), (DV3MM-HB)Summary page 1…(Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System) Predicate Device: MDL2110A (K050485) Device Description: MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is a 21.3-inch Monochrome LC… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K050485.
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?
21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052199: 21.3-Inch (54 CM) Monochrome LCD Monitor MDL2115A (ME353I), (DV3MM-HB), (ME353IM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052199
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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