510(k) · Cleared

Cleared

Stroke VCAR

K152584510(k) TraditionalCleared Jan 20, 2016132-day reviewClass II21 CFR 892.1750

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

GE Medical Systems SCS · JAK System, X-Ray, Tomography, Computed

Cleared on Jan 20, 2016 as substantially equivalent to K041521 (General Electric Medical Systems, 2004) after a 132-day review. Its family tree reaches back 3 generations to 1987.

Decided: Jan 20, 2016
Review: 132 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K871859 (1987). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
2 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
1 generation backK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
This deviceK152584 Stroke VCARGE Medical Systems SCS · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K871859	CT9800 Quick 3D #B7919DA	General Electric Co.	1987	—
−2	K972399	Advantage Windows Volume Rendering Option	Ge Medical Systems, Inc.	1997	1
−1	K041521	Volume Viewer Plus	General Electric Medical Systems	2004	2
0 (this device)	K152584	Stroke VCAR	GE Medical Systems SCS	2016	—

Other ancestors by year cleared

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

FIG. 1 — Lineage of K152584, 1987–2016Source: 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.

Planning a device in JAK? 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? (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
*	K041521	Volume Viewer Plus Summary page 4 …de Name: Stroke VCAR Common/Usual Name: Stroke VCAR Classification Names: 21CFR 892.1750, Radiology Product Code: JAK Predicate Device(s): K041521 - Volume Viewer Plus Device Description / Stroke VCAR is intended to provide 2D and 3D processing, Intended Us…	General Electric Medical Systems	2004	2

Also cleared against K041521: 16 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 10.1 years on median.
3 of the 6 ancestors have a recall of any class.
16 other devices also cite its predicate K041521.

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. 2016, this device’s year, is highlighted.

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?

Stroke VCAR is a CT image analysis software package that provides information to physicians to assist them in the analysis and visualization of Brain CT data derived from DICOM 3.0 compliant CT scans. Stroke VCAR is designed for the purpose of segmenting and assessing intracerebral and intracranial hemorrhages in the brain using semi-automated tools on non-contrast CT exams. Additionally Stroke VCAR provides a set of workflow tools for the segmentation…

Read the full statement (134 words)

This software will assist the user by providing initial 3D segmentation, measurements and visualization of hemorrhages and aneurysm in the brain. The user has the ability to adjust, review and has to confirm the final segmentation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152584 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152584: Stroke VCAR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152584

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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