510(k) · Cleared

Recalled · Class II · 2012

Advantage Workstation 4.1

K020483510(k) TraditionalCleared Feb 28, 200215-day reviewClass II21 CFR 892.2050Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Medical Systems · LLZ System, Image Processing, Radiological

Cleared on Feb 28, 2002 as substantially equivalent to K960613 (GE Medical Systems, 1996) after a 15-day review. Its family tree reaches back 2 generations to 1991. 1 of the 876 devices in its family, counting itself, has a Class I recall. 872 later devices descend from it. It has been recalled 2 times.

Decided: Feb 28, 2002
Review: 15 days
Class: Class II
Product code: LLZ
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K913770 (1991). 3 ancestors in all. 872 later devices descend from it, 5 citing it directly. 1 of the 876 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
1 generation backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
This deviceK020483 Advantage Workstation 4.1GE Medical Systems · 2002
Descendant · cites it directly · 637 of its ownK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
Descendant · 2 generations on · 324 of its ownK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
Descendant · 3 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Descendant · 2 generations on · 263 of its ownK043216 Cadstream Version 4.0Confirma, Inc. · 2005
Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009

Showing 5 of 872 descendants. See all descendants

Descendants cleared per year

2002high 87 (2025) · low 1 (2002)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025

Most influential descendants

Showing 5 of 872 · See all

K033400Seno AdvantageGe Medical Systems W-400 · 2003 · cites it directly637descendants
K043415Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · 2 generations on324descendants
K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 3 generations on287descendants
K043216Cadstream Version 4.0Confirma, Inc. · 2005 · 2 generations on263descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K913770	Advantage V.S. CT/MR Rad Diagnostic Workstation	General Electric Co.	1991	—
−1	K960613	GE Advantage Windows Review Workstation	GE Medical Systems	1996	—
0 (this device)	K020483	Advantage Workstation 4.1	GE Medical Systems	2002	—
+1	K033400	Seno Advantage	Ge Medical Systems W-400	2003	6
+2	K043415	Centricity Pacs System	Ge Medical Systems Information Technologies	2005	23
+3	K071964	Mim 4.1 (Seastar)	Mimvista Corp.	2007	2
+2	K043216	Cadstream Version 4.0	Confirma, Inc.	2005	—
+4	K091373	Syngo Trued	Siemens Medical Solutions USA, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	3	0
2004	9	0
2005	12	0
2006	12	0
2007	13	0
2008	14	0
2009	19	0
2010	9	0
2011	17	0
2012	26	0
2013	20	0
2014	33	0
2015	36	0
2016	37	0
2017	45	0
2018	59	0
2019	46	0
2020	53	0
2021	63	0
2022	63	0
2023	57	0
2024	71	0
2025	87	1
2026	67	0

FIG. 1 — Lineage of K020483, 1991–2026Source: 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.

1 device in this family has a Class I recall. 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? (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
*	K960613	GE Advantage Windows Review Workstation Summary page 1 …Workstation is substantially equivalent to the devices listed below: Model: Advantage Windows Review Workstation Manufacturer: General Electric Medical Systems 510 (k): K960613 Device Description : Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing and filming…	GE Medical Systems	1996	—

Also cleared against K960613: 5 other devices →

What descends from it? (872)

See all 872

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

Number	Device	Applicant	Decided	Descendants
K033400	Seno Advantage	Ge Medical Systems W-400	2003	637
K023003	Imagechecker-CT Workstation	R2 Technology, Inc.	2002	177
K032748	VITREA2, Version 3.4 Medical Image Processing Software	Vital Images, Inc.	2003	170
K052995	Advantage Workstation 4.3.	GE Healthcare	2005	113
K183193	MREplus+ Software	Resoundant, Inc.	2019	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 24, 2012	Class II	Z-2203-2012	Software design	GE Healthcare is informing you of incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed they are asking you not to use the aorta analysis protocol or the…
Sep 10, 2007	Not classified	Z-0265-2008	Software design	Aortic Length over-estimated: incorrect measurements when using the Aorta analysis protocol or customized protocols. Until a new software version is installed the aorta analysis protocol or the customized protocols for an aneurysm should…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K033400 (Ge Medical Systems W-400, 2003) has gone furthest, with 637 descendants of its own.
5 other devices also cite its predicate K960613.

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 Advantage Workstation 4.1 is a review station, which allows easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis.

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/K020483 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020483: Advantage Workstation 4.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020483

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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