510(k) · Cleared
Cleared5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)
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 Jul 21, 2006 as substantially equivalent to K041737 (Totoku Electric Co., Ltd., 2004) after a 57-day review. Its family tree reaches back 6 generations to 1991. 13 later devices descend from it.
- Decided
- Jul 21, 2006
- Review
- 57 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). 13 later devices descend from it, 4 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 backK041737 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004
- This deviceK061447 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006
- Descendant · cites it directly · 4 of its ownK081242 21.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2…Tokotu Electric Co., Ltd. · 2008
- Descendant · cites it directly · 4 of its ownK071794 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd. · 2008
- Descendant · cites it directly · 3 of its ownK090947 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model…Totoku Electric Co., Ltd. · 2010
- Descendant · 2 generations on · 3 of its ownK081945 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd. · 2008
- Descendant · 3 generations on · 2 of its ownK113443 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd. · 2008 · cites it directly4descendants
- K07179415M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd. · 2008 · cites it directly4descendants
- K09094721.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)Totoku Electric Co., Ltd. · 2010 · cites it directly3descendants
- K08194521.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd. · 2008 · 2 generations on3descendants
- K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011 · 3 generations on2descendants
View 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 | K041737 | 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) | Totoku Electric Co., Ltd. | 2004 | — |
| 0 (this device) | K061447 | 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2) | Totoku Electric Co., Ltd. | 2006 | — |
| +1 | K081242 | 21.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A) | Tokotu Electric Co., Ltd. | 2008 | — |
| +1 | K071794 | 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) | Totoku Electric Co., Ltd. | 2008 | — |
| +1 | K090947 | 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A) | Totoku Electric Co., Ltd. | 2010 | — |
| +2 | K081945 | 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A) | Totoku Electric Co., Ltd. | 2008 | — |
| +3 | K113443 | 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023) | Totoku Electric Co., Ltd. | 2011 | — |
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 |
|---|---|---|
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K041737 | 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Summary page 1….2050 Picture Archiving and Communication System) Predicate Device: 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) (K041737) Device Description: MDL2116A (ME551i2) is a 21.3-inch 5 megapixcel monochrome LCD monitor who… | 2004 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081242 | 21.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A) | 2008 | 4 |
| K071794 | 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) | 2008 | 4 |
| K090947 | 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A) | 2010 | 3 |
| K111496 | 21.3 Inch (54CM) Monochrome Digital Mammography LCD Monitor | 2011 | 2 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K081242 (Tokotu Electric Co., Ltd., 2008) has gone furthest, with 4 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?
5M Monochrome Digital Mammography LCD Monitor MDL2116A (MES51i2) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061447 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061447: 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061447
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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