510(k) · Cleared

Cleared

Somatom Definition

K052216510(k) TraditionalCleared Sep 8, 200536-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 Systems, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Sep 8, 2005 as substantially equivalent to K013522 (Siemens Medical Systems, Inc., 2001) and 1 other predicate after a 36-day review. Its family tree reaches back 3 generations to 2001. 38 later devices descend from it.

Decided: Sep 8, 2005
Review: 36 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K013561 (2001). 5 ancestors in all, the oldest K982349 (1998). 38 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
2 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
1 generation backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
This deviceK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
Descendant · cites it directly · 36 of its ownK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
Descendant · 2 generations on · 32 of its ownK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
Descendant · 2 generations on · 31 of its ownK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
Descendant · 3 generations on · 29 of its ownK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Descendant · cites it directly · 28 of its ownK122471 Somatom DefinitionSiemens Medical Systems, Inc. · 2012 · Recalled

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2008high 4 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 38 · See all

K082220Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008 · cites it directly36descendants
K113342Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · 2 generations on32descendants
K121072Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · 2 generations on31descendants
K133589Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · 3 generations on29descendants
K122471Somatom DefinitionSiemens Medical Systems, Inc. · 2012 · cites it directly28descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K013561	Lightspeed 4.0 CT Scanner System	GE Medical Systems	2001	5
−2	K030420	Lightspeed 5.0 Computed Tomography System	GE Medical Systems	2003	4
−1	K040372	Lightspeed 7.0 CT Scanner System	Ge Medical Systems, LLC	2004	5
0 (this device)	K052216	Somatom Definition	Siemens Medical Systems, Inc.	2005	—
+1	K082220	Somatom Flash DS	Siemens Medical Solutions USA, Inc.	2008	—
+2	K113342	Somatom Definition Flash	Siemens Medical Systems, Inc.	2011	1
+2	K121072	Somatom Definition Flash	Siemens Medical Systems, Inc.	2012	5
+3	K133589	Somatom Force	Siemens Medical Solutions USA, Inc.	2014	9
+1	K122471	Somatom Definition	Siemens Medical Systems, Inc.	2012	3

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	2	0
2012	2	0
2014	2	0
2015	2	0
2016	3	0
2017	3	0
2018	2	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 K052216, 2001–2026Source: 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
*	K013522	Somatom P30 CT Systems Summary page 1 …FDA Clearance Number FDA Clearance Date Predicate Device Name K013522 11/07/2001 Siemens SOMATOM Sensation 64 K040372…	Siemens Medical Systems, Inc.	2001	9
*	K040372	Lightspeed 7.0 CT Scanner System Summary page 1 …K013522 11/07/2001 Siemens SOMATOM Sensation 64 K040372 03/01/2004 E LightSpeed VCT…	Ge Medical Systems, LLC	2004	5

Also cleared against K013522: 4 other devices →

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K082220	Somatom Flash DS	Siemens Medical Solutions USA, Inc.	2008	36
K122471	Somatom Definition	Siemens Medical Systems, Inc.	2012	28

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 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
4 of the 5 ancestors have a recall of any class.
Of its descendants, K082220 (Siemens Medical Solutions USA, Inc., 2008) has gone furthest, with 36 descendants of its own.
4 other devices also cite its predicate K013522.

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 P45 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/K052216 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052216: Somatom Definition.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052216

Report an extraction error

Are you the manufacturer?

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