510(k) Report

510(k) · Cleared

Cleared

Barco Mammo Tomosynthesis

K103792510(k) TraditionalCleared Mar 4, 201167-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

Barco N.V. · LLZ System, Image Processing, Radiological

Cleared on Mar 4, 2011 after a 67-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 32 later devices descend from it.

Decided
Mar 4, 2011
Review
67 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

32 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2016: 6 descendants cleared2024: 4 descendants cleared2025: 2 descendants cleared2017: 3 descendants cleared2019: 1 descendant cleared2018: 1 descendant cleared2023: 6 descendants cleared2022: 2 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2026: 1 descendant cleared2010201520202025
  1. This deviceK103792 Barco Mammo TomosynthesisBarco N.V. · 2011
  2. Descendant · cites it directly · 30 of its ownK151883 5MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015
  3. Descendant · 2 generations on · 14 of its ownK162497 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016
  4. Descendant · 2 generations on · 12 of its ownK160326 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2…Jvckenwood Corporation · 2016
  5. Descendant · 3 generations on · 11 of its ownK172738 RadiForce RX560, RX560-AREizo Corporation · 2017
  6. Descendant · 3 generations on · 6 of its ownK191137 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 2019

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2015: 22016: 62017: 32018: 12019: 12020: 22021: 22022: 22023: 62024: 42025: 22026: 1
2015high 6 (2016) · low 1 (2018)2026

Most influential descendants

Showing 5 of 32 · See all
  • K1518835MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation · 2015 · cites it directly30descendants
  • K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation · 2016 · 2 generations on14descendants
  • K1603265MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)Jvckenwood Corporation · 2016 · 2 generations on12descendants
  • K172738RadiForce RX560, RX560-AREizo Corporation · 2017 · 3 generations on11descendants
  • K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation · 2019 · 3 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K103792Barco Mammo TomosynthesisBarco N.V.2011—
+1K1518835MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation2015—
+2K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation2016—
+2K1603265MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)Jvckenwood Corporation2016—
+3K172738RadiForce RX560, RX560-AREizo Corporation2017—
+3K1911375MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500Jvckenwood Corporation2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201660
201730
201810
201910
202020
202120
202220
202360
202440
202520
202610
FIG. 1 — Lineage of K103792, 2011–2026Source: 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? (32)

See all 32

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K1518835MP Monochrome LCD Monitor, RadiForce GX540Eizo Corporation201530
K160354MX50T (MX50TQS)Wide Corporation20160

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, K151883 (Eizo Corporation, 2015) has gone furthest, with 30 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. 2011, this device’s year, is highlighted.

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?

The Barco Mammo Tomosynthesis (MIDMVG-5221) device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners.

It is specially designed for breast tomosynthesis applications.

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

More from Barco N.V.

61 FDA decisions under this applicant name. See the company

  • K261469Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character).Barco N.V. · 2026
  • K243307LCD Monitor (MDEC-2523)Barco N.V. · 2024
  • K242008Coronis OneLookBarco N.V. · 2024
  • K233693Nio Color 8MP (MDNC-8132)Barco N.V. · 2023
  • K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. · 2023

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/K103792 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103792: Barco Mammo Tomosynthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103792

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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