510(k) · Cleared

Cleared

Vscore with Ekg Signal Gating

K001682510(k) TraditionalCleared Jun 30, 200029-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

Vital Images, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 30, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.

Decided: Jun 30, 2000
Review: 29 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 0

48 later devices descend from it, 2 citing it directly.

This deviceK001682 Vscore with Ekg Signal GatingVital Images, Inc. · 2000
Descendant · cites it directly · 45 of its ownK072737 CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007
Descendant · 2 generations on · 29 of its ownK083446 Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009
Descendant · 3 generations on · 25 of its ownK111373 CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011
Descendant · 4 generations on · 17 of its ownK203256 Imbio RV/LV SoftwareImbio, LLC · 2021
Descendant · 2 generations on · 14 of its ownK172983 HealthCCSZebra Medical Vision, Ltd. · 2018

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2001high 10 (2024) · low 0 (2002)2026

Most influential descendants

Showing 5 of 48 · See all

K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C · 2007 · cites it directly45descendants
K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc. · 2009 · 2 generations on29descendants
K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc. · 2011 · 3 generations on25descendants
K203256Imbio RV/LV SoftwareImbio, LLC · 2021 · 4 generations on17descendants
K172983HealthCCSZebra Medical Vision, Ltd. · 2018 · 2 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001682	Vscore with Ekg Signal Gating	Vital Images, Inc.	2000	—
+1	K072737	CSCS-001A Calcium Scoring Package	Toshiba America Medical Systems, In.C	2007	—
+2	K083446	Cardiac Function Analysis, Calcium Scoring	Ziosoft, Inc.	2009	—
+3	K111373	CT42 Cardiac Computed Tomography (CT) Software	Circle Cardiovascular Imaging, Inc.	2011	—
+4	K203256	Imbio RV/LV Software	Imbio, LLC	2021	—
+2	K172983	HealthCCS	Zebra Medical Vision, Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	1	0
2007	1	0
2009	1	0
2011	1	0
2015	1	0
2018	2	0
2019	1	0
2020	2	0
2021	2	0
2022	5	0
2023	7	0
2024	10	0
2025	10	0
2026	3	0

FIG. 1 — Lineage of K001682, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (48)

See all 48

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

Number	Device	Applicant	Decided	Descendants
K072737	CSCS-001A Calcium Scoring Package	Toshiba America Medical Systems, In.C	2007	45
K013146	Viatronic V3D Calcium Scoring	Viatronix, Inc.	2001	1

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?

Of its descendants, K072737 (Toshiba America Medical Systems, In.C, 2007) has gone furthest, with 45 descendants of its own.

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	—

https://510kreport.com/device/K001682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001682: Vscore with Ekg Signal Gating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001682

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026