510(k) · Cleared

Cleared

Somatom Care Contrast CT

K043087510(k) TraditionalCleared Dec 15, 200437-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

Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Dec 15, 2004 as substantially equivalent to K023687 (Siemens Medical Systems, Inc., 2002) and 2 other predicates after a 37-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.

Decided: Dec 15, 2004
Review: 37 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K982349 (1998). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
2 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
1 generation backK040577 Somatom Project P30LSiemens Medical Systems, Inc. · 2004 · Recalled
This deviceK043087 Somatom Care Contrast CTSiemens Medical Solutions USA, Inc. · 2004
Descendant · cites it directly · 1 of its ownK061976 Ckis-004A Injector Synchronization OptionToshiba America Medical Systems, In.C · 2006
Descendant · cites it directly · 0 of its ownK082960 GE Xtreme Injector OptionGe Medical Systems, LLC · 2008

Most influential descendants

Showing 2 of 2 · See all

K061976Ckis-004A Injector Synchronization OptionToshiba America Medical Systems, In.C · 2006 · cites it directly1descendant
K082960GE Xtreme Injector OptionGe Medical Systems, LLC · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K982349	Somatom Plus 4WITH Volume Zoom CT Scanners	Siemens Medical Solutions USA, Inc.	1998	—
−2	K013522	Somatom P30 CT Systems	Siemens Medical Systems, Inc.	2001	9
−1	K040577	Somatom Project P30L	Siemens Medical Systems, Inc.	2004	2
0 (this device)	K043087	Somatom Care Contrast CT	Siemens Medical Solutions USA, Inc.	2004	—
+1	K061976	Ckis-004A Injector Synchronization Option	Toshiba America Medical Systems, In.C	2006	—
+1	K082960	GE Xtreme Injector Option	Ge Medical Systems, LLC	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0

FIG. 1 — Lineage of K043087, 1998–2008Source: 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? (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
*	K023687	Somatom Emotion 6 CT Systems Summary page 2 …le software package: PredicateDevice Name FDA ClearanceNumber FDA ClearanceDate Siemens SOMATOM Emotion 6 (PI OF) K023687 11/22/2002 Siemens SOMATOM Sensation 64 K040665 04/02/2004…	Siemens Medical Systems, Inc.	2002	6
*	K040665	Somatom Sensation 64 and Sensation Cardiac Summary page 2 …mber FDA ClearanceDate Siemens SOMATOM Emotion 6 (PI OF) K023687 11/22/2002 Siemens SOMATOM Sensation 64 K040665 04/02/2004 (P30F) Siemens SOMATOM Sensation Open K040577…	Siemens Medical Solutions USA, Inc.	2004	5
*	K040577	Somatom Project P30L Summary page 2 …Siemens SOMATOM Sensation 64 K040665 04/02/2004 (P30F) Siemens SOMATOM Sensation Open K040577 03/22/2004 (P30L) 5. Device Description CARE Contrast CT for the SOMATO…	Siemens Medical Systems, Inc.	2004	2

Also cleared against K023687: 5 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K061976	Ckis-004A Injector Synchronization Option	Toshiba America Medical Systems, In.C	2006	1
K082960	GE Xtreme Injector Option	Ge Medical Systems, LLC	2008	0

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 6 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
4 of the 5 ancestors have a recall of any class.
Of its descendants, K061976 (Toshiba America Medical Systems, In.C, 2006) has gone furthest, with 1 descendant of its own.
5 other devices also cite its predicate K023687.

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?

CARE Contrast CT is designed to facilitate contrast enhanced CT examinations by connecting CT and injector. If CARE Contrast CT is activated, the contrast enhanced examination can be started by pressing one single start button, either at the CT scanner or at the injector. CARE Contrast CT is based on the future standard for the communication between CT and injector.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043087 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043087: Somatom Care Contrast CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043087

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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