510(k) · Cleared
Cleared21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)
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 Oct 27, 2011 as substantially equivalent to K081056 (Totoku Electric Co., Ltd., 2008) after a 50-day review. Its family tree reaches back 5 generations to 2004. 3 later devices descend from it.
- Decided
- Oct 27, 2011
- Review
- 50 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K032555 (2004). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK032555 3M Color Medical Flat Panel Display, CCL316Totoku Electric Co., Ltd. · 2004
- 4 generations backK043430 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HBTotoku Electric Co., Ltd. · 2005
- 3 generations backK050619 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I &…Totoku Electric Co., Ltd. · 2005
- 2 generations backK072065 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)Totoku Electric Co., Ltd. · 2007
- 1 generation backK081056 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Totoku Electric Co., Ltd. · 2008
- This deviceK112604 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK133185 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358)Jvckenwood Corporation · 2013
- Descendant · 2 generations on · 1 of its ownK140214 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)Jvckenwood Corporation · 2014
- Descendant · 3 generations on · 0 of its ownK212985 6MP Color LCD Monitor CL-S600Jvckenwood Corporation · 2021
Most influential descendants
Showing 3 of 3 · See all- K13318521.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358)Jvckenwood Corporation · 2013 · cites it directly2descendants
- K14021430.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)Jvckenwood Corporation · 2014 · 2 generations on1descendant
- K2129856MP Color LCD Monitor CL-S600Jvckenwood Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032555 | 3M Color Medical Flat Panel Display, CCL316 | Totoku Electric Co., Ltd. | 2004 | — |
| −4 | K043430 | 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HB | Totoku Electric Co., Ltd. | 2005 | — |
| −3 | K050619 | 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HB | Totoku Electric Co., Ltd. | 2005 | — |
| −2 | K072065 | 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2) | Totoku Electric Co., Ltd. | 2007 | — |
| −1 | K081056 | 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A) | Totoku Electric Co., Ltd. | 2008 | — |
| 0 (this device) | K112604 | 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356) | Totoku Electric Co., Ltd. | 2011 | — |
| +1 | K133185 | 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358) | Jvckenwood Corporation | 2013 | — |
| +2 | K140214 | 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6) | Jvckenwood Corporation | 2014 | — |
| +3 | K212985 | 6MP Color LCD Monitor CL-S600 | Jvckenwood Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K081056 | 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Summary page 1…ammography. Substantial Equivalence: CCL3S6i2 (CL21356) shares the same characteristics with our predicate device CCL3S4i2 (K081056) except for the power supply. TOTOKU ELECTRIC CO., LTD.… | 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 |
|---|---|---|---|
| K133185 | 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358) | 2013 | 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 7 years and passes through 1 company; a new generation was cleared every 11 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K133185 (Jvckenwood Corporation, 2013) has gone furthest, with 2 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. 2011, 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 (54 cm) Color 3M pixel LCD Monitor CCL3S6i2 (CL21356) 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/K112604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112604: 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112604
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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