510(k) · Cleared

Cleared

CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B

K023760510(k) TraditionalCleared Nov 22, 200214-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 22, 2002 as substantially equivalent to K013422 (GE Medical Systems, 2001) after a 14-day review. Its family tree reaches back 2 generations to 2000. 174 later devices descend from it.

Decided: Nov 22, 2002
Review: 14 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K000315 (2000). 174 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
1 generation backK013422 Cardiq FunctionGE Medical Systems · 2001
This deviceK023760 CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001BToshiba America Medical Systems, In.C · 2002
Descendant · cites it directly · 143 of its ownK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
Descendant · 2 generations on · 117 of its ownK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
Descendant · 3 generations on · 111 of its ownK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
Descendant · 4 generations on · 82 of its ownK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
Descendant · cites it directly · 29 of its ownK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009

Showing 5 of 174 descendants. See all descendants

Descendants cleared per year

2004high 21 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 174 · See all

K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · cites it directly143descendants
K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · 2 generations on117descendants
K061624Vitrea, Version 3.9Vital Images, Inc. · 2006 · 3 generations on111descendants
K071331Vitrea Version 4.0Vital Images, Inc. · 2007 · 4 generations on82descendants
K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009 · cites it directly29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000315	Ventricular Analysis Toolkit Option	GE Medical Systems	2000	—
−1	K013422	Cardiq Function	GE Medical Systems	2001	—
0 (this device)	K023760	CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B	Toshiba America Medical Systems, In.C	2002	—
+1	K043333	VITREA2, Version 3.7 Medical Image Processing System	Vital Images, Inc.	2004	1
+2	K052632	VITREA2 Version 3.8 Medical Image Processing Software	Vital Images, Inc.	2005	2
+3	K061624	Vitrea, Version 3.9	Vital Images, Inc.	2006	1
+4	K071331	Vitrea Version 4.0	Vital Images, Inc.	2007	1
+1	K083446	Cardiac Function Analysis, Calcium Scoring	Ziosoft, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	3	0
2007	6	0
2008	5	0
2009	8	0
2011	2	0
2012	9	0
2013	3	0
2014	7	0
2015	10	0
2016	4	0
2017	8	0
2018	9	0
2019	3	0
2020	6	0
2021	8	0
2022	15	0
2023	11	0
2024	21	0
2025	21	0
2026	12	0

FIG. 1 — Lineage of K023760, 2000–2026Source: 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? (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
*	K013422	Cardiq Function	GE Medical Systems	2001	—

Also cleared against K013422: 5 other devices →

What descends from it? (174)

See all 174

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

Number	Device	Applicant	Decided	Descendants
K043333	VITREA2, Version 3.7 Medical Image Processing System	Vital Images, Inc.	2004	143
K083446	Cardiac Function Analysis, Calcium Scoring	Ziosoft, Inc.	2009	29
K142736	XIDF-AWS801, Angio Workstation, v5.31	Toshibamedical Systems Corporation	2015	6

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 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K043333 (Vital Images, Inc., 2004) has gone furthest, with 143 descendants of its own.
5 other devices also cite its predicate K013422.

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 Cardiac Function Analysis (CFA) is a software package that can be used in conjunction with CT cardiac images to semi-automatically calculate and display various Left Ventricular and Right Ventricular functional parameters such as End Systolic and End Diastolic volumes, stroke volume, LV ejection fraction to include peak filling and ejection rates, Myocardial Mass calculations, regional wall motion display and analysis. When interpreted by a trained physician, the software aids in the assessment and in determination of cardiovascular disease diagnosis and management.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023760 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023760: CT Cardiac Function Analysis Software, Models CSCF-001A and CSCF-001B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023760

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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