510(k) · Cleared

Cleared

Medis 5MP2 Dual-Head Medical Diagnostic Display System

K001753510(k) TraditionalCleared Jul 27, 200049-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 NV Display Systems · LLZ System, Image Processing, Radiological

Cleared on Jul 27, 2000 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it.

Decided: Jul 27, 2000
Review: 49 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 0

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

This deviceK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
Descendant · cites it directly · 62 of its ownK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
Descendant · 2 generations on · 25 of its ownK023322 Coronis 2MP Medical Flat Panel Display SystemBarco N.V. · 2002
Descendant · 2 generations on · 17 of its ownK023341 Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002
Descendant · 3 generations on · 10 of its ownK033004 MFGD 2320 20 Inch 2 Megapixel Greyscale LCD DisplayBarco NV Barcoview · 2004
Descendant · 3 generations on · 10 of its ownK032202 Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2002high 16 (2004) · low 0 (2009)2026

Most influential descendants

Showing 5 of 64 · See all

K013922Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002 · cites it directly62descendants
K023322Coronis 2MP Medical Flat Panel Display SystemBarco N.V. · 2002 · 2 generations on25descendants
K023341Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002 · 2 generations on17descendants
K033004MFGD 2320 20 Inch 2 Megapixel Greyscale LCD DisplayBarco NV Barcoview · 2004 · 3 generations on10descendants
K032202Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003 · 3 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001753	Medis 5MP2 Dual-Head Medical Diagnostic Display System	Barco NV Display Systems	2000	—
+1	K013922	Coronis 3MP Medicl Flat Panel Display System	Barco N.V.	2002	—
+2	K023322	Coronis 2MP Medical Flat Panel Display System	Barco N.V.	2002	—
+2	K023341	Cornis 5MP Medical Flat Panel Display System	Barco N.V.	2002	—
+3	K033004	MFGD 2320 20 Inch 2 Megapixel Greyscale LCD Display	Barco NV Barcoview	2004	—
+3	K032202	Dome CX Digital Flat-Panel Display System, Models C2 and C5I	Planar Systems, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	6	0
2003	6	0
2004	16	0
2005	10	0
2006	10	0
2007	3	0
2008	3	0
2012	1	0
2013	1	0
2014	2	0
2015	1	0
2016	4	0
2017	1	0

FIG. 1 — Lineage of K001753, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (64)

See all 64

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

Number	Device	Applicant	Decided	Descendants
K013922	Coronis 3MP Medicl Flat Panel Display System	Barco N.V.	2002	62
K020061	Imagedesk	Barco N.V.	2002	0

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, K013922 (Barco N.V., 2002) has gone furthest, with 62 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

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

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

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

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	—

https://510kreport.com/device/K001753 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001753: Medis 5MP2 Dual-Head Medical Diagnostic Display System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001753

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026