510(k) · Cleared

Cleared

Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation Family CT

K140232510(k) TraditionalCleared Aug 14, 2014196-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 Aug 14, 2014 as substantially equivalent to K133424 (Siemens Medical Solutions USA, Inc., 2014) and 3 other predicates after a 196-day review. Its family tree reaches back 3 generations to 1998.

Decided: Aug 14, 2014
Review: 196 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K982349 (1998). 5 ancestors in all. No later device cites it as a predicate yet.

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 deviceK140232 Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation…Siemens Medical Solutions USA, Inc. · 2014

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)	K140232	Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation Family CT	Siemens Medical Solutions USA, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2014	1	0

FIG. 1 — Lineage of K140232, 1998–2014Source: 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? (4)

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
*	K133424	Somatom Emotion 6 CT Systems, Somatom Emotion 16 Summary page 5 …ce FDA Clearance Predicate Devices Number Date syngo® CT 2013A (SOMARIS/5 VC20B) K133424 January 17, 2014 SOMATOM Project P30F/ Sensation 64 K040655 April 2, 2004 SOMATOM Project P30L/…	Siemens Medical Solutions USA, Inc.	2014	5
*	K040665	Somatom Sensation 64 and Sensation Cardiac Our reading of the summary gave K040655, FDA’s number for Swift Anterior Cervical Plate System (Depuy Spine, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SOMATOM Project P30F/ Sensation 64”.	Siemens Medical Solutions USA, Inc.	2004	5
*	K040577	Somatom Project P30L Summary page 5 …K133424 January 17, 2014 SOMATOM Project P30F/ Sensation 64 K040655 April 2, 2004 SOMATOM Project P30L/ Sensation Open K040577 March 22, 2004 SOMATOM P30 CT Systems/ Sensation K013522 November 07, 2001 5. Device…	Siemens Medical Systems, Inc.	2004	2
*	K013522	Somatom P30 CT Systems Summary page 5 …K040655 April 2, 2004 SOMATOM Project P30L/ Sensation Open K040577 March 22, 2004 SOMATOM P30 CT Systems/ Sensation K013522 November 07, 2001 5. Device Description: syngo® CT 2014A (SOMARIS/5 VB42) is a new scanning software ver…	Siemens Medical Systems, Inc.	2001	9

Also cleared against K133424: 2 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 16 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
4 of the 5 ancestors have a recall of any class.
2 other devices also cite its predicate K133424.

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. 2014, this device’s year, is highlighted.

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 Emotion and SOMATOM Sensation family CT systems are 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 angles 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 translation of the patient.)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140232 · printed Nov 3, 2026

Cite this page

510(k) Report. “K140232: Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation Family CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K140232

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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