510(k) · Cleared

Recalled · 2011

Advantage Windows with Functool Option

K960265510(k) TraditionalCleared Jul 3, 1996167-day reviewClass II21 CFR 892.2050Recalls 1

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 Jul 3, 1996 as substantially equivalent to K913770 (General Electric Co., 1991) and 1 other predicate after a 167-day review. Its family tree reaches back 1 generation to 1991. 2 of the 183 devices in its family, counting itself, have a Class I recall. 180 later devices descend from it. It has been recalled once.

Decided: Jul 3, 1996
Review: 167 days
Class: Class II
Product code: LLZ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K913475 (1991). 2 ancestors in all. 180 later devices descend from it, 13 citing it directly. 2 of the 183 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
This deviceK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996
Descendant · cites it directly · 74 of its ownK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
Descendant · 2 generations on · 48 of its ownK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
Descendant · cites it directly · 38 of its ownK110573 Ready ViewGe Healthcare (Ge Medical Systems Scs) · 2011 · Recalled
Descendant · cites it directly · 32 of its ownK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
Descendant · cites it directly · 27 of its ownK063505 Visualase Envision Software SystemBiotex, Inc. · 2006

Showing 5 of 180 descendants. See all descendants

Descendants cleared per year

1998high 13 (2012) · low 0 (2000)2026

Class I recalls in this family

K143457 NeuroBlate System6 generations on · 2015
K171255 Monteris Medical NeuroBlate System6 generations on · 2017

Most influential descendants

Showing 5 of 180 · See all

K971965Philips EasyvisionPhilips Medical Systems, Inc. · 1998 · cites it directly74descendants
K022292Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Agfa Corp. · 2002 · 2 generations on48descendants
K110573Ready ViewGe Healthcare (Ge Medical Systems Scs) · 2011 · cites it directly38descendants
K061429Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006 · cites it directly32descendants
K063505Visualase Envision Software SystemBiotex, Inc. · 2006 · cites it directly27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913475	Magnetic Resonance Diagnostic Device	GE Medical Systems	1991	—
0 (this device)	K960265	Advantage Windows with Functool Option	GE Medical Systems	1996	—
+1	K971965	Philips Easyvision	Philips Medical Systems, Inc.	1998	—
+2	K022292	Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for…	Agfa Corp.	2002	9
+1	K110573	Ready View	Ge Healthcare (Ge Medical Systems Scs)	2011	1
+1	K061429	Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera	Esaote, S.p.A.	2006	—
+1	K063505	Visualase Envision Software System	Biotex, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2002	1	0
2003	5	0
2004	5	0
2005	7	0
2006	5	0
2007	2	0
2008	6	0
2009	8	0
2010	2	0
2011	7	0
2012	13	0
2013	9	0
2014	5	0
2015	9	1
2016	8	0
2017	9	1
2018	10	0
2019	5	0
2020	8	0
2021	7	0
2022	6	0
2023	6	0
2024	12	0
2025	9	0
2026	13	0

FIG. 1 — Lineage of K960265, 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.

2 devices in this family have 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? (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 …previously marketed devices. Conclusions It is the opinion of GE that the FuncTool Option is substantially equivalent to the Advantage Windows Diagnostic Workstation (K913770) and Signa Advantage (K913475) . The FuncTool Option does not include any new indications for use, nor does use of this device re…	General Electric Co.	1991	—
*	K913475	Magnetic Resonance Diagnostic Device Summary page 1 …GE's CT and MR Systems. Marketing History This software is presently being marketed as the Multiple Region of Interest (MIROI) function in the Signa MR Systems 510(k) K913475. FuncTool automates what is presently done manually. Comparison with Predicate The use of the FuncTool Option does not result i…	GE Medical Systems	1991	—

Also cleared against K913770: 3 other devices →

What descends from it? (180)

See all 180

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

Number	Device	Applicant	Decided	Descendants
K971965	Philips Easyvision	Philips Medical Systems, Inc.	1998	74
K110573	Ready View	Ge Healthcare (Ge Medical Systems Scs)	2011	38
K061429	Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera	Esaote, S.p.A.	2006	32
K063505	Visualase Envision Software System	Biotex, Inc.	2006	27
K031350	3TP Software Option	3tp, LLC	2003	19
K041286	Dynacad V1.0	Mri Devices Corp.	2004	17
K043350	Mistar, Model V3.2	Apollo Medical Imaging Technology Pty., Ltd.	2004	12
K052963	Mediq Version 1.0	Clario Medical Imaging, Inc.	2005	11
K050862	3TP Workspace	3tp, LLC	2005	10
K081556	Cadstream, Version 5.0	Confirma, Inc.	2009	9

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 18, 2011	Not classified	Z-3282-2011	Software design	GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This…

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.

K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K971965 (Philips Medical Systems, Inc., 1998) has gone furthest, with 74 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 FuncTool option to the Advantages Windows workstation is a software module that provides supplemental information to those images extracted from CT and MR temporal datasets.

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/K960265 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960265: Advantage Windows with Functool Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960265

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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