510(k) · Cleared

Cleared

Plaqueview Software, Model CSPV-0001A

K043111510(k) TraditionalCleared Nov 18, 20048-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

Toshiba America Medical Systems, In.C · JAK System, X-Ray, Tomography, Computed

Cleared on Nov 18, 2004 as substantially equivalent to K990426 (Siemens Medical Solutions USA, Inc., 1999) after an 8-day review. Its family tree reaches back 3 generations to 1995. 112 later devices descend from it.

Decided: Nov 18, 2004
Review: 8 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K945428 (1995). 4 ancestors in all. 112 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK945428 Scribe (TM) Diagnostic Imaging WorkstationMulti-Dimensional Imaging, Inc. · 1995
2 generations backK960911 Netra Workstation System & Netra MD SoftwareScimage, Inc. · 1996
1 generation backK990426 Calcium ScoringSiemens Medical Solutions USA, Inc. · 1999
This deviceK043111 Plaqueview Software, Model CSPV-0001AToshiba America Medical Systems, In.C · 2004
Descendant · cites it directly · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
Descendant · cites it directly · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
Descendant · cites it directly · 21 of its ownK073156 Qplaque MRMedis Medical Imaging Systems BV · 2008
Descendant · 2 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
Descendant · 2 generations on · 19 of its ownK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

2006high 14 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 112 · See all

K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · cites it directly111descendants
K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · cites it directly82descendants
K073156Qplaque MRMedis Medical Imaging Systems BV · 2008 · cites it directly21descendants
K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 2 generations on19descendants
K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009 · 2 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K945428	Scribe (TM) Diagnostic Imaging Workstation	Multi-Dimensional Imaging, Inc.	1995	—
−2	K960911	Netra Workstation System & Netra MD Software	Scimage, Inc.	1996	—
−1	K990426	Calcium Scoring	Siemens Medical Solutions USA, Inc.	1999	—
0 (this device)	K043111	Plaqueview Software, Model CSPV-0001A	Toshiba America Medical Systems, In.C	2004	—
+1	K061624	Vitrea, Version 3.9	Vital Images, Inc.	2006	1
+1	K071331	Vitrea Version 4.0	Vital Images, Inc.	2007	1
+1	K073156	Qplaque MR	Medis Medical Imaging Systems BV	2008	—
+2	K120636	Synapse 3D Cardiac Tools	Fujifilm Medical System U.S.A., Inc.	2012	—
+2	K092747	Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool	Philips Medical Systems (Cleveland), Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2007	5	0
2008	4	0
2009	5	0
2011	1	0
2012	7	0
2013	3	0
2014	6	0
2015	5	0
2016	3	0
2017	5	0
2018	8	0
2019	3	0
2020	4	0
2021	4	0
2022	8	0
2023	6	0
2024	10	0
2025	14	0
2026	9	0

FIG. 1 — Lineage of K043111, 1995–2026Source: 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.

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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K004126	General Electric Perfusion CT 2 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*	K990426	Calcium Scoring Summary page 1 …ic X-ray Equipment Standard Pi edicate Device(s): General Electric Perfusion CT 2 [K(004 1267] Siemens Perfusion CT [1(990426] Reson For Submission Modification of Cleared Device Dscription of this Device: Tie CSPV-OO1A is an image analy…	Siemens Medical Solutions USA, Inc.	1999	—

Also cleared against K990426: 4 other devices →

What descends from it? (112)

See all 112

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

Number	Device	Applicant	Decided	Descendants
K061624	Vitrea, Version 3.9	Vital Images, Inc.	2006	111
K071331	Vitrea Version 4.0	Vital Images, Inc.	2007	82
K073156	Qplaque MR	Medis Medical Imaging Systems BV	2008	21

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 9 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K061624 (Vital Images, Inc., 2006) has gone furthest, with 111 descendants of its own.
4 other devices also cite its predicate K990426.

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 PlaqueView (SurePlaque) tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multi-detector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043111 · printed Nov 3, 2026

Cite this page

510(k) Report. “K043111: Plaqueview Software, Model CSPV-0001A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043111

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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