510(k) Report

510(k) · Cleared

Cleared

3M Color Medical Flat Panel Display, CCL316

K032555510(k) TraditionalCleared Feb 26, 2004191-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Totoku Electric Co., Ltd. · LLZ System, Image Processing, Radiological

Cleared on Feb 26, 2004 after a 191-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.

Decided
Feb 26, 2004
Review
191 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2006: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK032555 3M Color Medical Flat Panel Display, CCL316Totoku Electric Co., Ltd. · 2004
  2. Descendant · cites it directly · 8 of its ownK043430 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HBTotoku Electric Co., Ltd. · 2005
  3. Descendant · 2 generations on · 7 of its ownK050619 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I &…Totoku Electric Co., Ltd. · 2005
  4. Descendant · 3 generations on · 5 of its ownK072065 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)Totoku Electric Co., Ltd. · 2007
  5. Descendant · 4 generations on · 4 of its ownK081056 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Totoku Electric Co., Ltd. · 2008
  6. Descendant · 5 generations on · 3 of its ownK112604 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 12008: 12011: 12013: 12014: 12021: 1
2005high 2 (2005) · low 0 (2009)2026

Most influential descendants

Showing 5 of 9 · See all
  • K04343020.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HBTotoku Electric Co., Ltd. · 2005 · cites it directly8descendants
  • K05061920.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HBTotoku Electric Co., Ltd. · 2005 · 2 generations on7descendants
  • K07206520.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)Totoku Electric Co., Ltd. · 2007 · 3 generations on5descendants
  • K08105621.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Totoku Electric Co., Ltd. · 2008 · 4 generations on4descendants
  • K11260421.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K0325553M Color Medical Flat Panel Display, CCL316Totoku Electric Co., Ltd.2004—
+1K04343020.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HBTotoku Electric Co., Ltd.2005—
+2K05061920.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HBTotoku Electric Co., Ltd.2005—
+3K07206520.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)Totoku Electric Co., Ltd.2007—
+4K08105621.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Totoku Electric Co., Ltd.2008—
+5K11260421.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200710
200810
201110
201310
201410
202110
FIG. 1 — Lineage of K032555, 2004–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K04343020.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HBTotoku Electric Co., Ltd.20058

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?

  • Of its descendants, K043430 (Totoku Electric Co., Ltd., 2005) has gone furthest, with 8 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

3M Color Medical Flat Panel Display, CCL316, is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians. It is not meant to be used for digital mammography.

Indications for use as stated in the FDA 510(k) statement.

More from Totoku Electric Co., Ltd.

40 FDA decisions under this applicant name. See the company

  • K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011
  • K11313621.3INCH (54CM)Color LCD Monitor CCL256I2(CL21256)Totoku Electric Co., Ltd. · 2011
  • K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd. · 2011
  • K11260421.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011
  • K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd. · 2011

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K032555 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032555: 3M Color Medical Flat Panel Display, CCL316.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032555

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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