510(k) · Cleared

Recalled · Class II · 2018

Somatom Scope/Somatom Scope Power

K140912510(k) TraditionalCleared Sep 15, 2014159-day reviewClass II21 CFR 892.1750Recalls 2

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 Sep 15, 2014 as substantially equivalent to K050297 (Siemens Medical Solution, Inc. USA, 2005) and 1 other predicate after a 159-day review. Its family tree reaches back 3 generations to 1994. 29 later devices descend from it. It has been recalled 2 times.

Decided: Sep 15, 2014
Review: 159 days
Class: Class II
Product code: JAK
Recalls: 2
Predicates: 2

Its longest line of descent runs back 3 generations to K940606 (1994). 8 ancestors in all. 29 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK940606 Hispeed Advantage IIGE Medical Systems · 1994
2 generations backK991716 Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc. · 1999 · Recalled
1 generation backK042328 Somatom SpiritSiemens Medical Systems, Inc. · 2004 · Recalled
This deviceK140912 Somatom Scope/Somatom Scope PowerSiemens 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 29 descendants. See all descendants

Descendants cleared per year

2015high 4 (2025) · low 1 (2015)2026

Most influential descendants

Showing 5 of 29 · 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
−3	K940606	Hispeed Advantage II	GE Medical Systems	1994	—
−2	K991716	Hispeed NX/I CT Scanner System	Ge Medical Systems, Inc.	1999	2
−1	K042328	Somatom Spirit	Siemens Medical Systems, Inc.	2004	2
0 (this device)	K140912	Somatom Scope/Somatom Scope Power	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

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2000	1	0
2002	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2016	3	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 K140912, 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

Get a 510(k) Report

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
*	K050297	Somatom Emotion 16 Summary page 5 …FDA Clearance Product Predicate Devices Number Date Code SOMATOM Emotion 16 K050297 03/01/2005 JAK SOMATOM Spirit K042328 09/14/2004 JAK 5. Device…	Siemens Medical Solution, Inc. USA	2005	8
*	K042328	Somatom Spirit Summary page 5 …Number Date Code SOMATOM Emotion 16 K050297 03/01/2005 JAK SOMATOM Spirit K042328 09/14/2004 JAK 5. Device Description: The SOMATOM Scope and SOMATOM Scope Power configured with software…	Siemens Medical Systems, Inc.	2004	2

Also cleared against K050297: 3 other devices →

What descends from it? (29)

See all 29

2 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
K151749	somatom Scope (with syngo CT VC30-easyIQ version), SOMATOM Scope Power (with syngo CT…	Siemens Medical Solutions USA, Inc.	2016	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 1, 2018	Class II	Z-2476-2018	Software design	A potential risk of unnecessary radiation exposure due to a software issue
Feb 1, 2018	Class II	Z-2477-2018	Software design	A potential risk of unnecessary radiation exposure due to a software issue

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
6 of the 8 ancestors have a recall of any class.
Of its descendants, K142955 (Siemens Medical Solutions USA, Inc., 2015) has gone furthest, with 27 descendants of its own.
3 other devices also cite its predicate K050297.

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 Scope and SOMATOM Scope Power 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/K140912 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140912: Somatom Scope/Somatom Scope Power.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140912

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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