510(k) · Cleared

Cleared

GE Advantage Windows Review Workstation

K960613510(k) TraditionalCleared Apr 30, 199677-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

GE Medical Systems · LLZ System, Image Processing, Radiological

Cleared on Apr 30, 1996 as substantially equivalent to K913770 (General Electric Co., 1991) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1991. 1 of the 917 devices in its family, counting itself, has a Class I recall. 914 later devices descend from it.

Decided: Apr 30, 1996
Review: 77 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K913770 (1991). 2 ancestors in all. 914 later devices descend from it, 6 citing it directly. 1 of the 917 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
This deviceK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
Descendant · cites it directly · 872 of its ownK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
Descendant · 2 generations on · 637 of its ownK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
Descendant · 3 generations on · 324 of its ownK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
Descendant · 4 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Descendant · 3 generations on · 263 of its ownK043216 Cadstream Version 4.0Confirma, Inc. · 2005

Showing 5 of 914 descendants. See all descendants

Descendants cleared per year

1997high 87 (2025) · low 0 (2000)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025

Most influential descendants

Showing 5 of 914 · See all

K020483Advantage Workstation 4.1GE Medical Systems · 2002 · cites it directly872descendants
K033400Seno AdvantageGe Medical Systems W-400 · 2003 · 2 generations on637descendants
K043415Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · 3 generations on324descendants
K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 4 generations on287descendants
K043216Cadstream Version 4.0Confirma, Inc. · 2005 · 3 generations on263descendants

View FIG. 1 as a table

Line of descent and top descendants

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

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
1997	1	0
1998	5	0
1999	1	0
2002	4	0
2003	3	0
2004	11	0
2005	14	0
2006	14	0
2007	16	0
2008	19	0
2009	19	0
2010	11	0
2011	21	0
2012	27	0
2013	24	0
2014	35	0
2015	39	0
2016	37	0
2017	45	0
2018	59	0
2019	46	0
2020	54	0
2021	64	0
2022	63	0
2023	57	0
2024	71	0
2025	87	1
2026	67	0

FIG. 1 — Lineage of K960613, 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

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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
*	K913770	Advantage V.S. CT/MR Rad Diagnostic Workstation Summary page 1 …age Windows Review Workstation. This is a device modification. Marketed Devices: lLegally marketed devices include the Advantage CT/MR Radiology Diagnostic Workstation (K913770) manufactured by GE Medical Systems and the Advantage Windows Diagnostic X- Ray Workstation (K942120) also manufactured by GE Med…	General Electric Co.	1991	—
*	K942120	Advantage Windows Diagnostic X-Ray Workstation Summary page 1 …evices include the Advantage CT/MR Radiology Diagnostic Workstation (K913770) manufactured by GE Medical Systems and the Advantage Windows Diagnostic X- Ray Workstation (K942120) also manufactured by GE Medical Systems. Device Description: The GE Advantage Windows Review Workstation consists of a Sun Micr…	GE Medical Systems	1994	—

Also cleared against K913770: 3 other devices →

What descends from it? (914)

See all 914

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

Number	Device	Applicant	Decided	Descendants
K020483	Advantage Workstation 4.1	GE Medical Systems	2002	872
K972701	Barco MWD 321 Medical Workstation Display	Barco NV Display Systems	1998	38
K980541	Barco MGD 521 5 Megapixel Diagnostic Display	Barco NV Display Systems	1998	33
K991629	GE View Applications (Consisting of GE Viewing Station and GE Extended Viewing Station)…	Ge Medical Systems, Inc.	1999	0
K983392	Data Ray Corporation DR11021 Medical Imaging Monitor	Data Ray	1998	0
K972103	Philips Easyvision	Philips Medical Systems North America, Inc.	1997	0

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

No FDA recall names this device.

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 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K020483 (GE Medical Systems, 2002) has gone furthest, with 872 descendants of its own.
3 other devices also cite its predicate K913770.

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 GE Advantage Windows Review Workstation is a two dimensional review station which allows selection and review of DICOM images from Computed Tomography (CT), Magnetic Resonance (MR), X-Ray (XR), Computed Radiography (CR) and Secondary Capture (SC) modalities.

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/K960613 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960613: GE Advantage Windows Review Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960613

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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