510(k) · Cleared

Recalled · Class II · 2012

Volume Viewer Plus

K041521510(k) TraditionalCleared Jun 22, 200414-day reviewClass II21 CFR 892.1750Recalls 2

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

General Electric Medical Systems · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 22, 2004 as substantially equivalent to K972399 (Ge Medical Systems, Inc., 1997) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1987. 1 of the 475 devices in its family, counting itself, has a Class I recall. 469 later devices descend from it. It has been recalled 2 times.

Decided: Jun 22, 2004
Review: 14 days
Class: Class II
Product code: JAK
Recalls: 2
Predicates: 2

Its longest line of descent runs back 2 generations to K871859 (1987). 5 ancestors in all. 469 later devices descend from it, 17 citing it directly. 1 of the 475 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 2 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
1 generation backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
This deviceK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004
Descendant · cites it directly · 217 of its ownK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
Descendant · cites it directly · 204 of its ownK063324 Pet VcarGE Healthcare · 2007 · Recalled
Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Descendant · 2 generations on · 195 of its ownK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
Descendant · 3 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009

Showing 5 of 469 descendants. See all descendants

Descendants cleared per year

2005high 47 (2025) · low 2 (2005)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025

Most influential descendants

Showing 5 of 469 · See all

K061696Iqqa-Liver SoftwareEdda Technology, Inc. · 2006 · cites it directly217descendants
K063324Pet VcarGE Healthcare · 2007 · cites it directly204descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
K071310Syngo CT Oncology Software PackageSiemens AG · 2007 · 2 generations on195descendants
K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 3 generations on117descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K871859	CT9800 Quick 3D #B7919DA	General Electric Co.	1987	—
−1	K972399	Advantage Windows Volume Rendering Option	Ge Medical Systems, Inc.	1997	1
0 (this device)	K041521	Volume Viewer Plus	General Electric Medical Systems	2004	—
+1	K061696	Iqqa-Liver Software	Edda Technology, Inc.	2006	—
+1	K063324	Pet Vcar	GE Healthcare	2007	1
+2	K091373	Syngo Trued	Siemens Medical Solutions USA, Inc.	2009	—
+2	K071310	Syngo CT Oncology Software Package	Siemens AG	2007	—
+3	K083524	Syngo Dual Energy with Extended Funationally	Siemens Medical Solutions USA, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2006	5	0
2007	5	0
2008	5	0
2009	5	0
2010	7	0
2011	11	0
2012	15	0
2013	14	0
2014	19	0
2015	19	0
2016	20	0
2017	20	0
2018	30	0
2019	25	0
2020	38	0
2021	32	0
2022	34	0
2023	35	0
2024	40	0
2025	47	1
2026	41	0

FIG. 1 — Lineage of K041521, 1987–2026Source: 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 JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 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
*	K972399	Advantage Windows Volume Rendering Option Summary page 1 …Advantage Windows Volume Rendering Option * Manufacturer: General Electric Medical Systems, Buc, France 510(k)#: K972399 * Model: CT Colonography / Navigator2 * Manufacturer: General Electric Medical Sys…	Ge Medical Systems, Inc.	1997	1
*	K012313	CT Colonography/NAVIGATOR2 Summary page 1 …del: CT Colonography / Navigator2 * Manufacturer: General Electric Medical Systems, Buc, France 510(k) #: K012313 Device Description: Volume Viewer Plus is a software package to be used on the GE Advantage Workstation, the GE Centricity PAC…	Ge Medical Systems, Inc.	2001	1

Also cleared against K972399: 1 other device →

What descends from it? (469)

See all 469

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

Number	Device	Applicant	Decided	Descendants
K061696	Iqqa-Liver Software	Edda Technology, Inc.	2006	217
K063324	Pet Vcar	GE Healthcare	2007	204
K052995	Advantage Workstation 4.3.	GE Healthcare	2005	113
K092639	Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…	GE Medical Systems SCS	2009	65
K070248	Velocityais	Velocity Medical Solutions, LLC	2007	65
K081076	Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response	Velocity Medical Solutions, LLC	2008	63
K110573	Ready View	Ge Healthcare (Ge Medical Systems Scs)	2011	38
K052345	Advantage Sim MD	GE Healthcare	2005	21
K131498	Iqqa-Liver Multimodality Software	Edda Technology, Inc.	2013	16
K141745	Iqqa-Bodyimaging Software	Edda Technology	2014	6

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 25, 2012	Class II	Z-0901-2013	Software design	Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation, Volume Viewer Plus and Volume Analysis.
May 1, 2008	Not classified	Z-2312-2008	Software design	GE Healthcare has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.

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

What does this lineage say?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.1 years on median.
2 of the 5 ancestors have a recall of any class.
Of its descendants, K061696 (Edda Technology, Inc., 2006) has gone furthest, with 217 descendants of its own.
1 other device also cites its predicate K972399.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

What is it indicated for?

Volume Viewer Plus is a medical diagnostic software that allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.

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/K041521 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041521: Volume Viewer Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041521

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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