510(k) · Cleared

Cleared

Somatom Plus 4 with Sliding Gantry Option

K991600510(k) SpecialCleared Jun 9, 199930-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 Corp. · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 9, 1999 as substantially equivalent to K990491 (Siemens Medical Solutions USA, Inc., 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1994. 32 later devices descend from it.

Decided: Jun 9, 1999
Review: 30 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K941546 (1994). 2 ancestors in all. 32 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK941546 Somatom Project 059Siemens Corp. · 1994
This deviceK991600 Somatom Plus 4 with Sliding Gantry OptionSiemens Corp. · 1999
Descendant · cites it directly · 27 of its ownK051765 Ceretom, Model NL3000Neurologica Corporation · 2005
Descendant · 2 generations on · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
Descendant · 2 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
Descendant · 2 generations on · 6 of its ownK171183 OmniTomNeurologica Corporation · 2017 · Recalled
Descendant · 2 generations on · 6 of its ownK061834 Xcat; Xcat for NeuroXoran Technologies, Inc. · 2006

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2003high 3 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 32 · See all

K051765Ceretom, Model NL3000Neurologica Corporation · 2005 · cites it directly27descendants
K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · 2 generations on10descendants
K102677Bodytom NL 4000Neurologica Corporation · 2011 · 2 generations on9descendants
K171183OmniTomNeurologica Corporation · 2017 · 2 generations on6descendants
K061834Xcat; Xcat for NeuroXoran Technologies, Inc. · 2006 · 2 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941546	Somatom Project 059	Siemens Corp.	1994	—
0 (this device)	K991600	Somatom Plus 4 with Sliding Gantry Option	Siemens Corp.	1999	—
+1	K051765	Ceretom, Model NL3000	Neurologica Corporation	2005	—
+2	K090811	Inspira HD, Model: NL1000	Neurologica Corporation	2009	—
+2	K102677	Bodytom NL 4000	Neurologica Corporation	2011	—
+2	K171183	OmniTom	Neurologica Corporation	2017	2
+2	K061834	Xcat; Xcat for Neuro	Xoran Technologies, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	1	0
2009	1	0
2011	1	0
2013	3	0
2014	1	0
2015	1	0
2016	3	0
2017	3	0
2018	2	0
2020	2	0
2022	3	0
2023	1	0
2024	2	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K991600, 1994–2026Source: 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.

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
*	K990491	Angio-CT Miyabi Summary page 2 …AY EQUIPMENT STANDARD FOR SAFETY. Substantial Equivalence: The SOMATOM Plus 4 CT Sliding Gantry Option is substantially equivalent to the Angio-CT MIYABI (described in K990491 cleared April 5, 1999) and SOMATOM Project 059 (described in K941546 cleared September 10, 1994) in commercial distribution. ign…	Siemens Medical Solutions USA, Inc.	1999	—
*	K941546	Somatom Project 059 Summary page 2 …TOM Plus 4 CT Sliding Gantry Option is substantially equivalent to the Angio-CT MIYABI (described in K990491 cleared April 5, 1999) and SOMATOM Project 059 (described in K941546 cleared September 10, 1994) in commercial distribution. ignature Date 510 (k) for SOMATOM Plus 4 with Sliding Gantry Option 05/…	Siemens Corp.	1994	—

Also cleared against K990491: 1 other device →

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K051765	Ceretom, Model NL3000	Neurologica Corporation	2005	27
K160611	P-Artis	P-Cure, Ltd.	2016	1
K032475	Somaton Computed Tomography X-Ray Systems Sliding Gantry Option	Siemens Medical Solutions USA, Inc.	2003	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?

None of the 2 ancestors has a recall.
Of its descendants, K051765 (Neurologica Corporation, 2005) has gone furthest, with 27 descendants of its own.
1 other device also cites its predicate K990491.

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?

The SOMATOM Plus 4 with Sliding Gantry Option is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous movement of the sliding gantry.)

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/K991600 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991600: Somatom Plus 4 with Sliding Gantry Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991600

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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