510(k) · Cleared

Recalled · Class II · 2024

Starspeed Series CT Scanner Systems

K052855510(k) TraditionalCleared Oct 28, 200517-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 Healthcare · JAK System, X-Ray, Tomography, Computed

Cleared on Oct 28, 2005 as substantially equivalent to K030420 (GE Medical Systems, 2003) and 3 other predicates after a 17-day review. Its family tree reaches back 2 generations to 2001. 6 of the 22 devices in its family, counting itself, have a Class I recall. 17 later devices descend from it. It has been recalled 5 times.

Decided: Oct 28, 2005
Review: 17 days
Class: Class II
Product code: JAK
Recalls: 5
Predicates: 4

Its longest line of descent runs back 2 generations to K013561 (2001). 4 ancestors in all, the oldest K000300 (2000). 17 later devices descend from it, 1 citing it directly. 6 of the 22 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
1 generation backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
This deviceK052855 Starspeed Series CT Scanner SystemsGE Healthcare · 2005
Descendant · cites it directly · 16 of its ownK082816 GE Brightspeed Delight CT Scanner SystemGe Medical Systems, LLC · 2008 · Recalled
Descendant · 2 generations on · 13 of its ownK093514 Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Recalled (Class I)
Descendant · 3 generations on · 6 of its ownK153402 Discovery NM/CT 670 CZTGE Healthcare · 2016 · Recalled (Class I)
Descendant · 4 generations on · 3 of its ownK182484 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018
Descendant · 5 generations on · 2 of its ownK190457 VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008high 3 (2025) · low 0 (2010)2026

Class I recalls in this family

K093514 Discovery Model NM/CT 6702 generations on · 2009
K153402 Discovery NM/CT 670 CZT3 generations on · 2016
K173816 NM/CT 850, NM/CT 8603 generations on · 2018
K111445 Discovery NM 6303 generations on · 2011

Most influential descendants

Showing 5 of 17 · See all

K082816GE Brightspeed Delight CT Scanner SystemGe Medical Systems, LLC · 2008 · cites it directly16descendants
K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 2 generations on13descendants
K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 3 generations on6descendants
K182484VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2018 · 4 generations on3descendants
K190457VERITON CT whole body SPECT/CT systemSpectrum Dynamics Medical, Ltd. · 2019 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K013561	Lightspeed 4.0 CT Scanner System	GE Medical Systems	2001	5
−1	K030420	Lightspeed 5.0 Computed Tomography System	GE Medical Systems	2003	4
0 (this device)	K052855	Starspeed Series CT Scanner Systems	GE Healthcare	2005	—
+1	K082816	GE Brightspeed Delight CT Scanner System	Ge Medical Systems, LLC	2008	9
+2	K093514	Discovery Model NM/CT 670	Ge Medical Systems F.I. Haifa	2009	Class I
+3	K153402	Discovery NM/CT 670 CZT	GE Healthcare	2016	Class I
+4	K182484	VERITON CT whole body SPECT/CT system	Spectrum Dynamics Medical, Ltd.	2018	—
+5	K190457	VERITON CT whole body SPECT/CT system	Spectrum Dynamics Medical, Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	1
2011	2	2
2012	1	1
2013	1	0
2016	1	1
2017	1	0
2018	2	1
2019	1	0
2021	1	0
2023	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K052855, 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

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What was it cleared against? (4)

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
*	K030420	Lightspeed 5.0 Computed Tomography System Summary page 2 …s image acquisition hardware, image acquisition and reconstruction software, and associated accessories. StarSpeed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, th…	GE Medical Systems	2003	4
*	K013561	Lightspeed 4.0 CT Scanner System Summary page 2 …peed Series is evolutionary modification to LightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (KO00300) 4 slice system. The StarSpeed Series…	GE Medical Systems	2001	5
*	K002978	Ligthspeed 3.0 CT Scanner System Summary page 2 …ightSpeed 5.0 (K030420) and incorporates the features, function, and some hardware of our current production LightSpeed 4.0 (K013561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (KO00300) 4 slice system. The StarSpeed Series is designed to be a head and whole body CT sc…	GE Medical Systems	2000	—
*	K000300	Lightspeed 2.0CT Scanner System Summary page 2 …features, function, and some hardware of our current production LightSpeed 4.0 (KO13561)16 slice system, the LightSpeed 3.0 (K002978) 8 slice system, and LightSpeed 2.0 (K000300) 4 slice system. It has the same technological characteristics and operating principles, is comparable in key safety and effectiv…	Ge Medical Systems, Inc.	2000	—

Also cleared against K030420: 5 other devices →

What descends from it? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082816	GE Brightspeed Delight CT Scanner System	Ge Medical Systems, LLC	2008	16

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 5, 2024	Class II	Z-0614-2025	Component design/selection	GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if…
May 24, 2018	Class II	Z-2587-2018	Component change control	Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
May 19, 2017	Class II	Z-2188-2017	Software design	It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
Sep 3, 2010	Not classified	Z-0369-2011	Software design	GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.
Sep 3, 2010	Not classified	Z-0368-2011	Software design	GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.

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

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K082816 (Ge Medical Systems, LLC, 2008) has gone furthest, with 16 descendants of its own.
5 other devices also cite its predicate K030420.

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 StarSpeed Series CT Scanner Systems are 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/K052855 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052855: Starspeed Series CT Scanner Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052855

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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