510(k) · Cleared

Cleared

Mediface Pacs

K010259510(k) TraditionalCleared Apr 26, 200187-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

Mediface Co., Ltd. · LLZ System, Image Processing, Radiological

Cleared on Apr 26, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 181 later devices descend from it.

Decided: Apr 26, 2001
Review: 87 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 0

181 later devices descend from it, 6 citing it directly.

This deviceK010259 Mediface PacsMediface Co., Ltd. · 2001
Descendant · cites it directly · 79 of its ownK031013 Infintt CO., LTD. Starpacs SystemInfinitt Company · 2003
Descendant · 2 generations on · 75 of its ownK033955 RTISTMirada Solutions, Ltd. · 2004
Descendant · cites it directly · 75 of its ownK012844 Marosis PacsMarotech, Inc. · 2001
Descendant · 3 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
Descendant · 2 generations on · 46 of its ownK032176 Rattan Imacs by Rattan Information CorporationRattan Information Corporation · 2003

Showing 5 of 181 descendants. See all descendants

Descendants cleared per year

2001high 17 (2022) · low 1 (2001)2026

Most influential descendants

Showing 5 of 181 · See all

K031013Infintt CO., LTD. Starpacs SystemInfinitt Company · 2003 · cites it directly79descendants
K033955RTISTMirada Solutions, Ltd. · 2004 · 2 generations on75descendants
K012844Marosis PacsMarotech, Inc. · 2001 · cites it directly75descendants
K101228Mirada XDMirada Medical, Ltd. · 2010 · 3 generations on70descendants
K032176Rattan Imacs by Rattan Information CorporationRattan Information Corporation · 2003 · 2 generations on46descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010259	Mediface Pacs	Mediface Co., Ltd.	2001	—
+1	K031013	Infintt CO., LTD. Starpacs System	Infinitt Company	2003	—
+2	K033955	RTIST	Mirada Solutions, Ltd.	2004	—
+1	K012844	Marosis Pacs	Marotech, Inc.	2001	—
+3	K101228	Mirada XD	Mirada Medical, Ltd.	2010	—
+2	K032176	Rattan Imacs by Rattan Information Corporation	Rattan Information Corporation	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	5	0
2004	5	0
2005	3	0
2006	7	0
2007	4	0
2008	5	0
2009	4	0
2010	6	0
2011	9	0
2012	1	0
2013	7	0
2014	5	0
2015	4	0
2016	8	0
2017	8	0
2018	10	0
2019	13	0
2020	7	0
2021	15	0
2022	17	0
2023	10	0
2024	7	0
2025	9	0
2026	10	0

FIG. 1 — Lineage of K010259, 2001–2026Source: 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? (181)

See all 181

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

Number	Device	Applicant	Decided	Descendants
K031013	Infintt CO., LTD. Starpacs System	Infinitt Company	2003	79
K012844	Marosis Pacs	Marotech, Inc.	2001	75
K032760	Apax Pacs System	Tis, Inc.	2003	19
K083555	Picture Archiving and Communication System (Pacs), Petavision	Emsoma Co., Ltd.	2008	3
K092081	Qxlink	Vieworks Co., Ltd.	2009	2
K023246	Amalga Pacs	Global Care Solutions, S.A.	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, K031013 (Infinitt Company, 2003) has gone furthest, with 79 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/K010259 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010259: Mediface Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010259

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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