510(k) · Cleared

Recalled · Class II · 2012

Advantage Windows Volume Rendering Option

K972399510(k) TraditionalCleared Sep 23, 199789-day reviewClass II21 CFR 892.1750Recalls 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, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Sep 23, 1997 as substantially equivalent to K923077 (GE Medical Systems, 1993) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1987. 1 of the 520 devices in its family, counting itself, has a Class I recall. 516 later devices descend from it. It has been recalled once.

Decided: Sep 23, 1997
Review: 89 days
Class: Class II
Product code: JAK
Recalls: 1
Predicates: 3

Its longest line of descent runs back 1 generation to K871859 (1987). 3 ancestors in all. 516 later devices descend from it, 2 citing it directly. 1 of the 520 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
This deviceK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997
Descendant · cites it directly · 469 of its ownK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
Descendant · 2 generations on · 217 of its ownK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
Descendant · 2 generations on · 204 of its ownK063324 Pet VcarGE Healthcare · 2007 · Recalled
Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Descendant · 3 generations on · 195 of its ownK071310 Syngo CT Oncology Software PackageSiemens AG · 2007

Showing 5 of 516 descendants. See all descendants

Descendants cleared per year

2003high 56 (2025) · low 1 (2003)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025

Most influential descendants

Showing 5 of 516 · See all

K041521Volume Viewer PlusGeneral Electric Medical Systems · 2004 · cites it directly469descendants
K061696Iqqa-Liver SoftwareEdda Technology, Inc. · 2006 · 2 generations on217descendants
K063324Pet VcarGE Healthcare · 2007 · 2 generations on204descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
K071310Syngo CT Oncology Software PackageSiemens AG · 2007 · 3 generations on195descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	2	0
2006	8	0
2007	5	0
2008	5	0
2009	7	0
2010	7	0
2011	13	0
2012	17	0
2013	17	0
2014	20	0
2015	20	0
2016	24	0
2017	21	0
2018	31	0
2019	26	0
2020	40	0
2021	33	0
2022	37	0
2023	36	0
2024	43	0
2025	56	1
2026	46	0

FIG. 1 — Lineage of K972399, 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

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What was it cleared against? (3)

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
*	K923077	Advantage Windows 3D Option and Dentascan Option Summary page 1 …Road ° New Berlin, W1 53151 Marketed Devices: The Advantage Windows Valume Rendering Option is substantially equivalent to the currently marketed Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (KB871859) Indications for Use: Advanta…	GE Medical Systems	1993	—
*	K954355	Advantage Windows 3D with Navigator Option Summary page 1 …vantage Windows Valume Rendering Option is substantially equivalent to the currently marketed Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (KB871859) Indications for Use: Advantage Windows Volurne Rendering Option is intended to pro…	General Electric Co.	1995	—
*	K871859	CT9800 Quick 3D #B7919DA Summary page 1 …stantially equivalent to the currently marketed Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (KB871859) Indications for Use: Advantage Windows Volurne Rendering Option is intended to provide fast, easy volume visualization of three…	General Electric Co.	1987	—

Also cleared against K923077: 2 other devices →

What descends from it? (516)

See all 516

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

Number	Device	Applicant	Decided	Descendants
K041521	Volume Viewer Plus	General Electric Medical Systems	2004	469
K031871	Autobone	Ge Medical Systems Europe	2003	58

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.

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

What does this lineage say?

None of the 3 ancestors has a recall.
Of its descendants, K041521 (General Electric Medical Systems, 2004) has gone furthest, with 469 descendants of its own.
2 other devices also cite its predicate K923077.

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?

The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).

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/K972399 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972399: Advantage Windows Volume Rendering Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972399

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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