510(k) · Cleared

Recalled · Class II · 2017

Lightspeed 7.1 CT Scanner System

K061817510(k) TraditionalCleared Jul 12, 200614-day reviewClass II21 CFR 892.1750Recalls 1

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

Ge Medical Systems, LLC · JAK System, X-Ray, Tomography, Computed

Cleared on Jul 12, 2006 as substantially equivalent to K040372 (Ge Medical Systems, LLC, 2004) after a 14-day review. Its family tree reaches back 3 generations to 2001. 45 later devices descend from it. It has been recalled once.

Decided: Jul 12, 2006
Review: 14 days
Class: Class II
Product code: JAK
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K013561 (2001). 45 later devices descend from it, 3 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 deviceK061817 Lightspeed 7.1 CT Scanner SystemGe Medical Systems, LLC · 2006
Descendant · cites it directly · 35 of its ownK081105 GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · Recalled
Descendant · 2 generations on · 28 of its ownK120833 Discovery CT750 HDGe Medical Systems, LLC · 2012 · Recalled
Descendant · 3 generations on · 21 of its ownK133705 Revolution CTGe Medical Systems, LLC · 2014 · Recalled
Descendant · 4 generations on · 15 of its ownK163213 Revolution CTGe Medical Systems, LLC · 2016 · Recalled
Descendant · 2 generations on · 10 of its ownK103489 GE Veo Reconstruction OptionGeneral Electric Co. · 2011

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2008high 4 (2019) · low 0 (2015)2026

Most influential descendants

Showing 5 of 45 · See all

K081105GE Lightspeed CT750 HD (Lightspeed 8.0)GE Healthcare · 2008 · cites it directly35descendants
K120833Discovery CT750 HDGe Medical Systems, LLC · 2012 · 2 generations on28descendants
K133705Revolution CTGe Medical Systems, LLC · 2014 · 3 generations on21descendants
K163213Revolution CTGe Medical Systems, LLC · 2016 · 4 generations on15descendants
K103489GE Veo Reconstruction OptionGeneral Electric Co. · 2011 · 2 generations on10descendants

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)	K061817	Lightspeed 7.1 CT Scanner System	Ge Medical Systems, LLC	2006	—
+1	K081105	GE Lightspeed CT750 HD (Lightspeed 8.0)	GE Healthcare	2008	5
+2	K120833	Discovery CT750 HD	Ge Medical Systems, LLC	2012	1
+3	K133705	Revolution CT	Ge Medical Systems, LLC	2014	14
+4	K163213	Revolution CT	Ge Medical Systems, LLC	2016	16
+2	K103489	GE Veo Reconstruction Option	General Electric Co.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	3	0
2009	1	0
2010	1	0
2011	3	0
2012	3	0
2013	1	0
2014	3	0
2016	3	0
2018	2	0
2019	4	0
2020	3	0
2021	2	0
2022	4	0
2023	3	0
2024	3	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K061817, 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

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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
*	K040372	Lightspeed 7.0 CT Scanner System Summary page 2 …tion software, associated accessories and connections/interfaces to accessories. The LightSpeed 7.1 Scanner System is an evolutionary modification to LightSpeed 7.0 (K040372). It is developed from the hardware platform of LightSpeed 7.0 32/64 slice system by adding new application features that…	Ge Medical Systems, LLC	2004	5

Also cleared against K040372: 3 other devices →

What descends from it? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K081105	GE Lightspeed CT750 HD (Lightspeed 8.0)	GE Healthcare	2008	35
K082761	GE Lightspeed 7.2 CT Scanner System	Ge Medical Systems, LLC	2008	7
K083504	GE Discovery NM/CT 570C	Ge Medical Systems F.I. Haifa	2008	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 19, 2017	Class II	Z-2183-2017	Software design	It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
3 of the 3 ancestors have a recall of any class.
Of its descendants, K081105 (GE Healthcare, 2008) has gone furthest, with 35 descendants of its own.
3 other devices also cite its predicate K040372.

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061817: Lightspeed 7.1 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/K061817

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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