510(k) · Cleared

Cleared

Visage Pacs, Version 6.0/CS 3.1

K082269510(k) TraditionalCleared Dec 12, 2008123-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

Visage Imaging, Inc. · LLZ System, Image Processing, Radiological

Cleared on Dec 12, 2008 as substantially equivalent to K072205 (Mercury Computer Systems, Inc., 2007) and 1 other predicate after a 123-day review. Its family tree reaches back 5 generations to 1995. 20 later devices descend from it.

Decided: Dec 12, 2008
Review: 123 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K945188 (1995). 7 ancestors in all. 20 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 5 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
4 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
3 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
2 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
1 generation backK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
This deviceK082269 Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008
Descendant · cites it directly · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
Descendant · cites it directly · 5 of its ownK203249 Nucleus.ioNucleushealth, LLC · 2020 · Recalled
Descendant · 2 generations on · 5 of its ownK122205 EXINIExini Diagnostics AB · 2012
Descendant · 2 generations on · 3 of its ownK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
Descendant · 3 generations on · 2 of its ownK191262 aBSIExini Diagnostics AB · 2019

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2009high 3 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 20 · See all

K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · cites it directly6descendants
K203249Nucleus.ioNucleushealth, LLC · 2020 · cites it directly5descendants
K122205EXINIExini Diagnostics AB · 2012 · 2 generations on5descendants
K222476OmegaAI Image ViewerRamsoft, Inc. · 2022 · 2 generations on3descendants
K191262aBSIExini Diagnostics AB · 2019 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K945188	Cemax Vipstation and/or Software	Cemax, Inc.	1995	—
−4	K961023	Aidp (Accuimage Image Display Processor)	Accuimage, Inc.	1996	—
−3	K994329	Iivs Integrated Image Viewing Station	Terarecon,Inc.	2000	—
−2	K012086	Aquariusnet Server	Terarecon,Inc.	2001	—
−1	K072205	Visage Pacs/CS, Release Version 5.0	Mercury Computer Systems, Inc.	2007	—
0 (this device)	K082269	Visage Pacs, Version 6.0/CS 3.1	Visage Imaging, Inc.	2008	—
+1	K111319	Ibis Explorer and Markup Software	Medqia	2011	—
+1	K203249	Nucleus.io	Nucleushealth, LLC	2020	1
+2	K122205	EXINI	Exini Diagnostics AB	2012	—
+2	K222476	OmegaAI Image Viewer	Ramsoft, Inc.	2022	—
+3	K191262	aBSI	Exini Diagnostics AB	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2011	2	0
2012	2	0
2015	1	0
2017	1	0
2018	1	0
2019	1	0
2020	1	0
2021	1	0
2022	2	0
2024	3	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K082269, 1995–2026Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K072205	Visage Pacs/CS, Release Version 5.0 Summary page 1 …II Review Panel: Radiology Product Classification: 90 LLZ, Picture Archiving and Communications System Previous 510(k) No.: K072205 E.X Substantial Equivalence The Visage PACS 6.0/CS 3.1 Software is substantially equivalent, in the opinion of Vis-…	Mercury Computer Systems, Inc.	2007	—
*	K011142	Aquarius Workstation Summary page 2 …Product Classification: 90 LLZ, Picture Archiving and Communications System USATrade name: Aquarius Workstation 510(k) No.: K011142 Classification Name: Picture Archiving and Communications System Reference: per 21 CFR 892.20…	Terarecon,Inc.	2001	—

Also cleared against K072205: 3 other devices →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K111319	Ibis Explorer and Markup Software	Medqia	2011	6
K203249	Nucleus.io	Nucleushealth, LLC	2020	5
K093703	3DI	Shina Systems, Ltd.	2010	2
K092134	Stat Pacs Picture Archiving & Communication System (Pacs)	Statrad, LLC	2009	1
K253927	LiveMedica Enterprise PACS	Live Medica, LLC	2026	0
K142196	Visage Ease Pro	Visage Imaging GmbH	2015	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?

The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K111319 (Medqia, 2011) has gone furthest, with 6 descendants of its own.
3 other devices also cite its predicate K072205.

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. 2008, this device’s year, is highlighted.

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?

Visage PACS/IS is a system for distributing, viewing, processing, and archiving medical images within and outside health care environments. The Visage PACS/CS server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations. The supported modalities are listed in the DICOM Conformance Statement. Besides general image interpretation and processing tools, Visage PACS/CS…

Read the full statement (238 words)

Visage PACS/IS is a system for distributing, viewing, processing, and archiving medical images within and outside health care environments.

The Visage PACS/CS server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities, and workstations. The supported modalities are listed in the DICOM Conformance Statement.

Besides general image interpretation and processing tools, Visage PACS/CS provides specific tool sets for several clinical applications, including:

- CT/MR angiography, e.g. for vascular analysis and stent planning

- Cardiac analysis, including calcium scoring and functional assessment of cardiac CT data

Neuroradiology, including CT and MR brain perfusion analysis

Oncology, including SUV analysis and lesion marking and analysis

Visage PACS/CS is to be used only by trained and instructed health care professionals. It can support physicians and/or their medical staff in providing their own diagnosis for medical cases. The final decision regarding diagnoses, however, resides with the doctors and/or their medical staff in their own area of responsibility.

Although -the web fiad-hfiie- - n ftechfoniesi ajiow- the ,sob-ii/' to- be rUnin6io a variety of hardware platforms, for diagnostic purposes the user must make sure that the display hardware used for reading the images complies with state-of-the-art diagnostic requirements and currently valid laws.

Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis.

Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082269 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082269: Visage Pacs, Version 6.0/CS 3.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082269

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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