510(k) · Cleared

Recalled · Class II · 2016

Lightspeed 4.0 CT Scanner System

K013561510(k) TraditionalCleared Nov 8, 200113-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

GE Medical Systems · JAK System, X-Ray, Tomography, Computed

Cleared on Nov 8, 2001 after a 13-day review. The FDA summary names no predicate by number. 6 of the 114 devices in its family, counting itself, have a Class I recall. 113 later devices descend from it. It has been recalled 5 times.

Decided: Nov 8, 2001
Review: 13 days
Class: Class II
Product code: JAK
Recalls: 5
Predicates: 0

113 later devices descend from it, 3 citing it directly. 6 of the 114 devices in this family, counting this one, have a Class I recall.

This deviceK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001
Descendant · cites it directly · 112 of its ownK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
Descendant · 2 generations on · 86 of its ownK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
Descendant · 3 generations on · 45 of its ownK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · Recalled
Descendant · 3 generations on · 38 of its ownK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
Descendant · 4 generations on · 36 of its ownK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008

Showing 5 of 113 descendants. See all descendants

Descendants cleared per year

2003high 10 (2025) · low 0 (2007)2026

Class I recalls in this family

K093514 Discovery Model NM/CT 6703 generations on · 2009
K153402 Discovery NM/CT 670 CZT4 generations on · 2016
K173816 NM/CT 850, NM/CT 8604 generations on · 2018
K111445 Discovery NM 6304 generations on · 2011

Most influential descendants

Showing 5 of 113 · See all

K030420Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · cites it directly112descendants
K040372Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · 2 generations on86descendants
K061817Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006 · 3 generations on45descendants
K052216Somatom DefinitionSiemens Medical Systems, Inc. · 2005 · 3 generations on38descendants
K082220Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008 · 4 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013561	Lightspeed 4.0 CT Scanner System	GE Medical Systems	2001	—
+1	K030420	Lightspeed 5.0 Computed Tomography System	GE Medical Systems	2003	4
+2	K040372	Lightspeed 7.0 CT Scanner System	Ge Medical Systems, LLC	2004	5
+3	K061817	Lightspeed 7.1 CT Scanner System	Ge Medical Systems, LLC	2006	1
+3	K052216	Somatom Definition	Siemens Medical Systems, Inc.	2005	—
+4	K082220	Somatom Flash DS	Siemens Medical Solutions USA, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	2	0
2005	3	0
2006	2	0
2008	6	0
2009	2	1
2010	1	0
2011	8	2
2012	6	1
2013	2	0
2014	6	0
2015	3	0
2016	7	1
2017	4	0
2018	6	1
2019	8	0
2020	6	0
2021	5	0
2022	5	0
2023	7	0
2024	6	0
2025	10	0
2026	6	0

FIG. 1 — Lineage of K013561, 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.

6 devices in this family have a Class I recall. 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?

The FDA summary names no predicate by number.

What descends from it? (113)

See all 113

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

Number	Device	Applicant	Decided	Descendants
K030420	Lightspeed 5.0 Computed Tomography System	GE Medical Systems	2003	112
K052855	Starspeed Series CT Scanner Systems	GE Healthcare	2005	17
K151372	Low Dose CT Lung Cancer Screening Option for Qualified GE Systems	Ge Medical Systems, LLC	2015	0

Has anything in its family been recalled? (6 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 10, 2016	Class II	Z-1048-2016	Labeling design	GE Healthcare has updated the Service Manuals for a number of CT and PET CT Scanners to update an incorrect torque value.
Jul 17, 2015	Class II	Z-2801-2015	Process control	Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Discovery LS PET CT scanner.
Apr 22, 2015	Class II	Z-1623-2015	Process design	GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the component becomes loose…
Jul 25, 2011	Class II	Z-1188-2013	Process control	Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking…
Dec 8, 2003	Not classified	Z-0306-04	Other	Incorrect mounting hardware may cause X-ray tube to separate from the gantry and fall.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K111445Discovery NM 630GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K113350Brivo NM 615GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K121019Optima NM/CT 640GE Healthcare · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls

Nearest 5 of 6; all are on the web page.

What does this lineage say?

Of its descendants, K030420 (GE Medical Systems, 2003) has gone furthest, with 112 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.

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 LightSpeed 4 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013561 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013561: Lightspeed 4.0 CT Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013561

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026