510(k) · Cleared

Recalled · Class II · 2018

Somatom Emotion 16

K050297510(k) SpecialCleared Mar 1, 200522-day reviewClass II21 CFR 892.1750Recalls 8

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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

Cleared on Mar 1, 2005 as substantially equivalent to K023687 (Siemens Medical Systems, Inc., 2002) after a 22-day review. Its family tree reaches back 1 generation to 2002. 34 later devices descend from it. It has been recalled 8 times.

Decided: Mar 1, 2005
Review: 22 days
Class: Class II
Product code: JAK
Recalls: 8
Predicates: 1

Its longest line of descent runs back 1 generation to K023687 (2002). 34 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK023687 Somatom Emotion 6 CT SystemsSiemens Medical Systems, Inc. · 2002 · Recalled
This deviceK050297 Somatom Emotion 16Siemens Medical Solution, Inc. USA · 2005
Descendant · cites it directly · 30 of its ownK113287 Somatom PerspectiveSiemens Medical Solutions USA, Inc. · 2012 · Recalled
Descendant · cites it directly · 29 of its ownK140912 Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Descendant · cites it directly · 29 of its ownK133590 Somatom PerspectiveSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Descendant · 2 generations on · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
Descendant · 3 generations on · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2009high 4 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 34 · See all

K113287Somatom PerspectiveSiemens Medical Solutions USA, Inc. · 2012 · cites it directly30descendants
K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · cites it directly29descendants
K133590Somatom PerspectiveSiemens Medical Solutions USA, Inc. · 2014 · cites it directly29descendants
K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on27descendants
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023687	Somatom Emotion 6 CT Systems	Siemens Medical Systems, Inc.	2002	6
0 (this device)	K050297	Somatom Emotion 16	Siemens Medical Solution, Inc. USA	2005	—
+1	K113287	Somatom Perspective	Siemens Medical Solutions USA, Inc.	2012	2
+1	K140912	Somatom Scope/Somatom Scope Power	Siemens Medical Solutions USA, Inc.	2014	2
+1	K133590	Somatom Perspective	Siemens Medical Solutions USA, Inc.	2014	1
+2	K142955	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM…	Siemens Medical Solutions USA, Inc.	2015	16
+3	K161196	SOMATOM Drive	Siemens Medical Solutions USA, Inc.	2016	4

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2012	1	0
2014	2	0
2015	1	0
2016	4	0
2017	3	0
2018	2	0
2019	3	0
2020	2	0
2021	2	0
2022	1	0
2023	3	0
2024	3	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K050297, 2002–2026Source: 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? (1)

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 1 …in commercial distribution: Predicate Device Name FDA Clearance Number FDA Clearance Date Siemens SOMATOM Emotion 6 K023687 11/22/2002 Siemens Medical Solutions, Inc. USA Page 7 Spec…	Siemens Medical Systems, Inc.	2002	6

Also cleared against K023687: 5 other devices →

What descends from it? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K113287	Somatom Perspective	Siemens Medical Solutions USA, Inc.	2012	30
K140912	Somatom Scope/Somatom Scope Power	Siemens Medical Solutions USA, Inc.	2014	29
K133590	Somatom Perspective	Siemens Medical Solutions USA, Inc.	2014	29
K083852	Biograph 16 True Point Systems	Siemens Medical Solutions USA, Inc.	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 15, 2018	Class II	Z-1454-2018	Software design	to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull…
Feb 15, 2018	Class II	Z-1459-2018	Software design	To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull…
Feb 15, 2018	Class II	Z-1452-2018	Software design	to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull…
Feb 15, 2018	Class II	Z-1453-2018	Software design	to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull…
Feb 15, 2016	Class II	Z-1301-2016	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…
Mar 21, 2014	Class II	Z-1721-2014	Component design/selection	The rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.
Aug 5, 2008	Not classified	Z-2453-2008	Nonconforming Material/Component	Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to…
Mar 9, 2006	Not classified	Z-0793-06	Other	When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K113287 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 30 descendants 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?

The Siemens SOMATOM Emotion 16 system 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 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/K050297 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050297: 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/K050297

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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