510(k) · Cleared
Cleared21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)
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 12, 2008 as substantially equivalent to K063198 (Totoku Electric Co., Ltd., 2006) and 1 other predicate after a 66-day review. Its family tree reaches back 8 generations to 1991. 3 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 66 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913770 (1991). 26 ancestors in all, the oldest K885042 (1988). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
- 5 generations backK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
- 4 generations backK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
- 3 generations backK041737 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004
- 2 generations backK061447 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006
- 1 generation backK081242 21.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2…Tokotu Electric Co., Ltd. · 2008
- This deviceK081945 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)Totoku Electric Co., Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK113443 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK133511 21.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation · 2013
- Descendant · 3 generations on · 0 of its ownK210345 2MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011 · cites it directly2descendants
- K13351121.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025)Jvckenwood Corporation · 2013 · 2 generations on1descendant
- K2103452MP Monochrome LCD Monitor MS-S200Jvckenwood Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K972701 | Barco MWD 321 Medical Workstation Display | Barco NV Display Systems | 1998 | — |
| −5 | K980541 | Barco MGD 521 5 Megapixel Diagnostic Display | Barco NV Display Systems | 1998 | — |
| −4 | K033859 | Barcoview MGD 521M Digital Mammography Display | Barco NV Barcoview | 2004 | — |
| −3 | K041737 | 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) | Totoku Electric Co., Ltd. | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K081945 | 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A) | Totoku Electric Co., Ltd. | 2008 | — |
| +1 | K113443 | 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023) | Totoku Electric Co., Ltd. | 2011 | — |
| +2 | K133511 | 21.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025) | Jvckenwood Corporation | 2013 | — |
| +3 | K210345 | 2MP Monochrome LCD Monitor MS-S200 | Jvckenwood Corporation | 2021 | — |
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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K063198 | 21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Summary page 1…ture Archiving and Communication System) Predicate Device: 21.3-inch (54cm) Monochrome LCD Monitor MDL2121A (ME253i2) (K063198) 21.3-inch (53cm) Monochrome LCD Monitor MS51i2 (MDL2123A) (K… | 2006 |
| * | K081242 | 21.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Summary page 1…(K063198) 21.3-inch (53cm) Monochrome LCD Monitor MS51i2 (MDL2123A) (K081242) Device Description: MS21i2 (MDL2127A) is a 21.3-inch (54 cm) Monochrome LCD mon… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113443 | 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023) | 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 17 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K113443 (Totoku Electric Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K063198.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 with sub-pixel driving techniques enabling
6M subpixels to be driven independently, MS21i2 (MDL2127A) is intended to be used in
displaying and viewing medical images for diagnosis by trained medical practitioners. It
is not meant to be used in digital mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081945: 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081945
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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