510(k) · Cleared

Cleared

Medicheart, Model Release 1

K032823510(k) TraditionalCleared Nov 10, 200361-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

Medicsight · JAK System, X-Ray, Tomography, Computed

Cleared on Nov 10, 2003 as substantially equivalent to K020929 (GE Medical Systems, 2002) and 2 other predicates after a 61-day review. Its family tree reaches back 4 generations to 1995.

Decided: Nov 10, 2003
Review: 61 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K945512 (1995). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK945512 HRSW Option for CT Twin FlashElscint, Inc. · 1995
3 generations backK970980 Cardiac Scoring for CT ScannersElscint, Inc. · 1997
2 generations backK982004 CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage…General Electric Co. · 1998
1 generation backK013146 Viatronic V3D Calcium ScoringViatronix, Inc. · 2001
This deviceK032823 Medicheart, Model Release 1Medicsight · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K945512	HRSW Option for CT Twin Flash	Elscint, Inc.	1995	—
−3	K970980	Cardiac Scoring for CT Scanners	Elscint, Inc.	1997	—
−2	K982004	CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows	General Electric Co.	1998	—
−1	K013146	Viatronic V3D Calcium Scoring	Viatronix, Inc.	2001	—
0 (this device)	K032823	Medicheart, Model Release 1	Medicsight	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0
2002	2	0

FIG. 1 — Lineage of K032823, 1995–2003Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K020929	Smartscore 3.5; Smartscore 4.0; Smartscore 4.5	GE Medical Systems	2002	—
*	K013146	Viatronic V3D Calcium Scoring Summary page 1 …510(k) No. G E Medical Systems SMARTSCORE 3.5; 4.0; 4.5 KO20929 V IA.I'RON IX V3D CALCIUM SCORING K 0 1 3 1 46 VOXAR CALCIUM SCORING PRODUCT KO20 140 rnedtcsight Device Descript…	Viatronix, Inc.	2001	—
*	K020140	Voxar's Calcium Scoring Product	Voxar Limited	2002	—

Also cleared against K020929: 4 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 8 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
None of the 8 ancestors has a recall.
4 other devices also cite its predicate K020929.

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?

MedicHeart 1 is a PC-based, stand-alone, non-invasive, image analysis software application intended to assist radiologists and other clinicians in the identification and quantification of coronary calcified plaques in the coronary arteries from CT image data. This quantification allows for evaluation of the progression or regression of calcified plaques in coronary arteries over time.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032823 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032823: Medicheart, Model Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032823

Report an extraction error

Are you the manufacturer?

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