510(k) · Cleared

Cleared

GE Road Warrior Pet CT Imaging System

K022872510(k) SpecialCleared Sep 12, 200214-day reviewClass II21 CFR 892.1200

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

General Electric Co. · KPS System, Tomography, Computed, Emission

Cleared on Sep 12, 2002 as substantially equivalent to K010641 (Ge Medical Systems, Inc., 2001) after a 14-day review. Its family tree reaches back 1 generation to 2001. 1 of the 400 devices in its family, counting itself, has a Class I recall. 398 later devices descend from it.

Decided: Sep 12, 2002
Review: 14 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010641 (2001). 398 later devices descend from it, 2 citing it directly. 1 of the 400 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
This deviceK022872 GE Road Warrior Pet CT Imaging SystemGeneral Electric Co. · 2002
Descendant · cites it directly · 396 of its ownK041543 GE Discovery STGE Healthcare · 2004 · Recalled
Descendant · 2 generations on · 380 of its ownK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
Descendant · 3 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
Descendant · 4 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Descendant · 5 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009

Showing 5 of 398 descendants. See all descendants

Descendants cleared per year

2003high 42 (2025) · low 1 (2003)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025

Most influential descendants

Showing 5 of 398 · See all

K041543GE Discovery STGE Healthcare · 2004 · cites it directly396descendants
K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · 2 generations on380descendants
K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 3 generations on350descendants
K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 4 generations on287descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 5 generations on200descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010641	GE CT-Pet System	Ge Medical Systems, Inc.	2001	—
0 (this device)	K022872	GE Road Warrior Pet CT Imaging System	General Electric Co.	2002	—
+1	K041543	GE Discovery ST	GE Healthcare	2004	1
+2	K042863	Scenium	Siemens Molecular Imaging, Ltd.	2004	—
+3	K060816	Mim 4.0 (Neuro	Mimvista Corp.	2006	1
+4	K071964	Mim 4.1 (Seastar)	Mimvista Corp.	2007	2
+5	K091373	Syngo Trued	Siemens Medical Solutions USA, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2005	1	0
2006	4	0
2007	3	0
2008	4	0
2009	1	0
2010	6	0
2011	6	0
2012	12	0
2013	8	0
2014	16	0
2015	14	0
2016	17	0
2017	18	0
2018	26	0
2019	23	0
2020	32	0
2021	27	0
2022	33	0
2023	34	0
2024	31	0
2025	42	1
2026	37	0

FIG. 1 — Lineage of K022872, 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.

1 device in this family has 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 KPS device

#1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 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
*	K010641	GE CT-Pet System Summary page 1 …mputed Tomography System, 21 CFR 892.1200, 90-KPS Marketed Device: GE Medical Systems GE Discovery LS Positron Emission Tomography System, 51O(k) Number K010641, currently in commercial distribution. Device Description: The GE Road Warrior PET CT Imaging System integrates a GE Positron Emi…	Ge Medical Systems, Inc.	2001	—

Also cleared against K010641: 3 other devices →

What descends from it? (398)

See all 398

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

Number	Device	Applicant	Decided	Descendants
K041543	GE Discovery ST	GE Healthcare	2004	396
K030199	GE Mobile Discovery ST Pet CT Imaging System	General Electric Co.	2003	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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.

K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K041543 (GE Healthcare, 2004) has gone furthest, with 396 descendants of its own.
3 other devices also cite its predicate K010641.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, 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	8	38	22	38
2008	17	25	16	11
2009	9	42	14	15
2010	3	91	4	44
2011	7	28	34	56
2012	6	94	13	34
2013	11	84	13	240
2014	11	92	18	33
2015	3	112	5	24
2016	11	65	16	10
2017	11	104	11	31
2018	13	59	12 (3)	26
2019	3	60	5 (5)	105
2020	12	72	8	22
2021	15	66	4	10
2022	5	60	8 (6)	15
2023	12	63	6 (3)	22
2024	11	59	15	23
2025	12	65	16	36
2026	6	67	6	—

What is it indicated for?

The GE Road Warrior PET CT Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitating localization of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022872 · printed Nov 5, 2026

Cite this page

510(k) Report. “K022872: GE Road Warrior Pet CT Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022872

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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