510(k) · Cleared

Cleared

Cardiac Scoring for CT Scanners

K970980510(k) TraditionalCleared May 29, 199772-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

Elscint, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on May 29, 1997 as substantially equivalent to K945512 (Elscint, Inc., 1995) after a 72-day review. Its family tree reaches back 1 generation to 1995. 1 of the 278 devices in its family, counting itself, has a Class I recall. 276 later devices descend from it.

Decided: May 29, 1997
Review: 72 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945512 (1995). 276 later devices descend from it, 2 citing it directly. 1 of the 278 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
This deviceK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
Descendant · cites it directly · 274 of its ownK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
Descendant · 2 generations on · 272 of its ownK020929 Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002
Descendant · 3 generations on · 217 of its ownK022919 Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002
Descendant · 4 generations on · 216 of its ownK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
Descendant · 5 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009

Showing 5 of 276 descendants. See all descendants

Descendants cleared per year

1998high 34 (2025) · low 0 (2000)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025

Most influential descendants

Showing 5 of 276 · See all

K982004CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage WindowsGeneral Electric Co. · 1998 · cites it directly274descendants
K020929Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems · 2002 · 2 generations on272descendants
K022919Smart Breath Respiratory Compensation OptionGE Medical Systems · 2002 · 3 generations on217descendants
K032915Advantage 4D OptionGe Medical Systems, LLC · 2003 · 4 generations on216descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 5 generations on200descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945512	HRSW Option for CT Twin Flash	Elscint, Inc.	1995	—
0 (this device)	K970980	Cardiac Scoring for CT Scanners	Elscint, Inc.	1997	—
+1	K982004	CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows	General Electric Co.	1998	—
+2	K020929	Smartscore 3.5; Smartscore 4.0; Smartscore 4.5	GE Medical Systems	2002	—
+3	K022919	Smart Breath Respiratory Compensation Option	GE Medical Systems	2002	—
+4	K032915	Advantage 4D Option	Ge Medical Systems, LLC	2003	—
+5	K091373	Syngo Trued	Siemens Medical Solutions USA, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2001	1	0
2002	2	0
2003	2	0
2005	2	0
2006	2	0
2007	2	0
2008	1	0
2009	2	0
2010	5	0
2011	3	0
2012	6	0
2013	4	0
2014	6	0
2015	8	0
2016	9	0
2017	9	0
2018	17	0
2019	14	0
2020	21	0
2021	16	0
2022	27	0
2023	24	0
2024	30	0
2025	34	1
2026	27	0

FIG. 1 — Lineage of K970980, 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.

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

Get a 510(k) Report

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
*	K945512	HRSW Option for CT Twin Flash Summary page 1 …ed on the Agaston scoring method for the quantification of high density structures, e.g. calcified tissues in the coronary arteries. 4. Predicate Devices CT Twin flash, K945512, 5. Safety The Level of Concern of the Cardiac Scoring was determined to be minor. The safety of this software option is assure…	Elscint, Inc.	1995	—

Also cleared against K945512: 3 other devices →

What descends from it? (276)

See all 276

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

Number	Device	Applicant	Decided	Descendants
K982004	CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows	General Electric Co.	1998	274
K990442	Advanced Diagnostic Viewer (Aox), Model Vitred 1.3	Vital Images, Inc.	1999	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K982004 (General Electric Co., 1998) has gone furthest, with 274 descendants of its own.
3 other devices also cite its predicate K945512.

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?

Cardiac scoring from whole body computed tomography derived measurements

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/K970980 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970980: Cardiac Scoring for CT Scanners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970980

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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