510(k) · Cleared

Cleared

Marosis Pacs

K012844510(k) TraditionalCleared Nov 8, 200177-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

Marotech, Inc. · LLZ System, Image Processing, Radiological

Cleared on Nov 8, 2001 as substantially equivalent to K010259 (Mediface Co., Ltd., 2001) after a 77-day review. Its family tree reaches back 1 generation to 2001. 75 later devices descend from it.

Decided: Nov 8, 2001
Review: 77 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010259 (2001). 75 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK010259 Mediface PacsMediface Co., Ltd. · 2001
This deviceK012844 Marosis PacsMarotech, Inc. · 2001
Descendant · cites it directly · 46 of its ownK032176 Rattan Imacs by Rattan Information CorporationRattan Information Corporation · 2003
Descendant · 2 generations on · 45 of its ownK063337 Opal-RadViztek, Inc. · 2006
Descendant · 3 generations on · 36 of its ownK102123 Vizion DRViztek, Inc. · 2011
Descendant · 4 generations on · 34 of its ownK112661 Vizion DRViztek, LLC · 2011
Descendant · 5 generations on · 33 of its ownK123644 Vizion + DRViztek, LLC · 2013

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2003high 7 (2019) · low 0 (2012)2026

Most influential descendants

Showing 5 of 75 · See all

K032176Rattan Imacs by Rattan Information CorporationRattan Information Corporation · 2003 · cites it directly46descendants
K063337Opal-RadViztek, Inc. · 2006 · 2 generations on45descendants
K102123Vizion DRViztek, Inc. · 2011 · 3 generations on36descendants
K112661Vizion DRViztek, LLC · 2011 · 4 generations on34descendants
K123644Vizion + DRViztek, LLC · 2013 · 5 generations on33descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010259	Mediface Pacs	Mediface Co., Ltd.	2001	—
0 (this device)	K012844	Marosis Pacs	Marotech, Inc.	2001	—
+1	K032176	Rattan Imacs by Rattan Information Corporation	Rattan Information Corporation	2003	—
+2	K063337	Opal-Rad	Viztek, Inc.	2006	—
+3	K102123	Vizion DR	Viztek, Inc.	2011	—
+4	K112661	Vizion DR	Viztek, LLC	2011	—
+5	K123644	Vizion + DR	Viztek, LLC	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	3	0
2004	3	0
2005	1	0
2006	5	0
2007	3	0
2008	3	0
2009	3	0
2010	3	0
2011	6	0
2013	3	0
2014	4	0
2015	1	0
2016	2	0
2017	3	0
2018	4	0
2019	7	0
2020	3	0
2021	7	0
2022	6	0
2023	1	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K012844, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K010259	Mediface Pacs Summary page 1 …Classification: 892.2050 Name: System, Image Processing Predicate Device: 21 CFR 807. 92(a)(3) Manufacturer: MEDIFACE CO., LTD. Device: MEDIFACE™ PACS 510(k) Number: K010259 Decision Date: 04/26/2001 Decision: Substantially Equivalent Panel Code device reviewed by: Radiology Panel Code device classi…	Mediface Co., Ltd.	2001	—

Also cleared against K010259: 5 other devices →

What descends from it? (75)

See all 75

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

Number	Device	Applicant	Decided	Descendants
K032176	Rattan Imacs by Rattan Information Corporation	Rattan Information Corporation	2003	46
K023460	Pacsplus	Medical Standard Co., Ltd.	2003	16
K040486	Medipacs	Neobit Co., Ltd.	2004	8
K063392	Imco-Stat	Imco Technologies	2006	1

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?

Its one ancestor has no recall.
Of its descendants, K032176 (Rattan Information Corporation, 2003) has gone furthest, with 46 descendants of its own.
5 other devices also cite its predicate K010259.

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	—

What is it indicated for?

The Marosis™ PACS System is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012844 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012844: Marosis Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012844

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026