510(k) · Cleared
Cleared21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A)
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 Aug 16, 2010 as substantially equivalent to K061447 (Totoku Electric Co., Ltd., 2006) and 1 other predicate after a 500-day review. Its family tree reaches back 8 generations to 1991. 3 later devices descend from it.
- Decided
- Aug 16, 2010
- Review
- 500 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913770 (1991). 20 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 backK071794 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Totoku Electric Co., Ltd. · 2008
- This deviceK090947 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model…Totoku Electric Co., Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK112145 Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK133686 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR…Jvckenwood Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK200161 3MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation · 2020
Most influential descendants
Showing 3 of 3 · See all- K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd. · 2011 · cites it directly2descendants
- K13368621.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)Jvckenwood Corporation · 2014 · 2 generations on1descendant
- K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300Jvckenwood Corporation · 2020 · 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 | K071794 | 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) | Totoku Electric Co., Ltd. | 2008 | — |
| 0 (this device) | K090947 | 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A) | Totoku Electric Co., Ltd. | 2010 | — |
| +1 | K112145 | Monochrome Digital Mammography LCD Monitor MS33I2 | Totoku Electric Co., Ltd. | 2011 | — |
| +2 | K133686 | 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2… | Jvckenwood Corporation | 2014 | — |
| +3 | K200161 | 3MP Monochrome Digital Mammography LCD Monitor MS-S300 | Jvckenwood Corporation | 2020 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K061447 | 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Summary page 1…Archiving and Communication System) Predicate Device: 5M Monochrome Digital Mammography LCD Monitor ME55112 (MDL2116A) (K061447) and MS5112 (MDL2123A) (K071794). Device Description: MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD… | 2006 |
| * | K071794 | 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2)Summary page 1…tem) Predicate Device: 5M Monochrome Digital Mammography LCD Monitor ME55112 (MDL2116A) (K061447) and MS5112 (MDL2123A) (K071794). Device Description: MS31i2 (MDL2128A) is a 21.3-inch (54 cm) monochrome LCD moni… | 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 |
|---|---|---|---|
| K112145 | Monochrome Digital Mammography LCD Monitor MS33I2 | 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 19 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K112145 (Totoku Electric Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K061447.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Digital Mammography 3M pixel LCD Monitor with sub-pixel driving techniques enabling 9M subpixels to be driven independently, MS31i2 (MDL2128A) 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/K090947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090947: 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model MS3112 (MDL2128A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090947
Report an extraction error
Are you the manufacturer?
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