510(k) · Cleared

Cleared

CT-Mass

K033774510(k) TraditionalCleared Mar 2, 200490-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

Medis Medical Imaging Systems BV · JAK System, X-Ray, Tomography, Computed

Cleared on Mar 2, 2004 as substantially equivalent to K013422 (GE Medical Systems, 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 2000.

Decided: Mar 2, 2004
Review: 90 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K000315 (2000). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK000315 Ventricular Analysis Toolkit OptionGE Medical Systems · 2000
1 generation backK013422 Cardiq FunctionGE Medical Systems · 2001
This deviceK033774 CT-MassMedis Medical Imaging Systems BV · 2004

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)	K033774	CT-Mass	Medis Medical Imaging Systems BV	2004	—

Other ancestors by year cleared

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

FIG. 1 — Lineage of K033774, 2000–2004Source: 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K013422	Cardiq Function Summary page 1 …vice Class. Narne Computed Tomography x-ray systems Regulation Number 21 CFR 892.1750 (90 JAK; Class II) 3. Predicate Device(s) GEMS: 510(k) K013422; K020796 4. Description of the device: CT-MASS is a professional state-of-the-art analytical software tool designed for UNIX, L…	GE Medical Systems	2001	—
*	K020796	Card IQ Analysis II Summary page 1 …s. Narne Computed Tomography x-ray systems Regulation Number 21 CFR 892.1750 (90 JAK; Class II) 3. Predicate Device(s) GEMS: 510(k) K013422; K020796 4. Description of the device: CT-MASS is a professional state-of-the-art analytical software tool designed for UNIX, Linux as w…	GE Medical Systems	2002	—

Also cleared against K013422: 5 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 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
None of the 4 ancestors has a recall.
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?

CT-MASS has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function from cardiac CT data sets. The itended purposes are:

1. Supporting clinical diagnoses about the status of the global and regional function and anatomy of the human heart;

2. Supporting the subsequent clinical decision making processes;

3. Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033774 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033774: CT-Mass.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033774

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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