510(k) · Cleared

Recalled · Class II · 2016

Somatom Emotion 6 CT Systems, Somatom Emotion 16

K133424510(k) SpecialCleared Jan 17, 201470-day reviewClass II21 CFR 892.1750Recalls 5

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 Jan 17, 2014 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it. It has been recalled 5 times.

Decided: Jan 17, 2014
Review: 70 days
Class: Class II
Product code: JAK
Recalls: 5
Predicates: 0

32 later devices descend from it, 3 citing it directly.

This deviceK133424 Somatom Emotion 6 CT Systems, Somatom Emotion 16Siemens Medical Solutions USA, Inc. · 2014
Descendant · cites it directly · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
Descendant · 2 generations on · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
Descendant · 2 generations on · 21 of its ownK162302 Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · Recalled
Descendant · 2 generations on · 20 of its ownK173630 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · Recalled
Descendant · 3 generations on · 19 of its ownK190578 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2019 · Recalled

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2014high 4 (2025) · low 1 (2014)2026

Most influential descendants

Showing 5 of 32 · See all

K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · cites it directly27descendants
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 2 generations on24descendants
K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · 2 generations on21descendants
K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · 2 generations on20descendants
K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc. · 2019 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K133424	Somatom Emotion 6 CT Systems, Somatom Emotion 16	Siemens Medical Solutions USA, Inc.	2014	—
+1	K142955	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM…	Siemens Medical Solutions USA, Inc.	2015	16
+2	K161196	SOMATOM Drive	Siemens Medical Solutions USA, Inc.	2016	4
+2	K162302	Somatom Confidence ® RT Pro	Siemens Medical Solutions USA, Inc.	2016	1
+2	K173630	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition…	Siemens Medical Solutions USA, Inc.	2018	4
+3	K190578	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition…	Siemens Medical Solutions USA, Inc.	2019	13

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	2	0
2016	2	0
2017	3	0
2018	3	0
2019	3	0
2020	3	0
2021	2	0
2022	1	0
2023	3	0
2024	3	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K133424, 2014–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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
K142955	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…	Siemens Medical Solutions USA, Inc.	2015	27
K151752	SOMATOM Emotion 6/16	Siemens Medical Solutions USA, Inc.	2015	2
K140232	Syngo CT 2014A (Somaris/5 VB42) for Somatom Emotion & Sensation Family CT	Siemens Medical Solutions USA, Inc.	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 15, 2016	Class II	Z-1302-2016	Device Design	Siemens is initiating this recall due to a potential malfunction and hence potential hazard to patients and personnel when using the SOMATOM Emotion or SOMATOM Sensation systems in conjunction with the use of the cardio licenses "Cardio…
Jun 4, 2015	Class II	Z-1934-2015	Device Design	A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
Jun 4, 2015	Class II	Z-1933-2015	Device Design	A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
Apr 20, 2015	Class II	Z-1645-2015	Software design	Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on…
Apr 20, 2015	Class II	Z-1644-2015	Software design	Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K142955 (Siemens Medical Solutions USA, Inc., 2015) has gone furthest, with 27 descendants of its own.

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	—

https://510kreport.com/device/K133424 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133424: Somatom Emotion 6 CT Systems, Somatom Emotion 16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133424

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026