510(k) · Cleared

Cleared

GE Mobile Discovery ST Pet CT Imaging System

K030199510(k) SpecialCleared Feb 11, 200321-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 Feb 11, 2003 as substantially equivalent to K022872 (General Electric Co., 2002) after a 21-day review. Its family tree reaches back 2 generations to 2001.

Decided: Feb 11, 2003
Review: 21 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K010641 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
1 generation backK022872 GE Road Warrior Pet CT Imaging SystemGeneral Electric Co. · 2002
This deviceK030199 GE Mobile Discovery ST Pet CT Imaging SystemGeneral Electric Co. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010641	GE CT-Pet System	Ge Medical Systems, Inc.	2001	—
−1	K022872	GE Road Warrior Pet CT Imaging System	General Electric Co.	2002	—
0 (this device)	K030199	GE Mobile Discovery ST Pet CT Imaging System	General Electric Co.	2003	—

FIG. 1 — Lineage of K030199, 2001–2003Source: 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 KPS? 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 18.7 · 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? (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
*	K022872	GE Road Warrior Pet CT Imaging System Summary page 1 …Emission Computed Tomography System, 21 CFR 892.1200,90-KPS Marketed Device: GE Medical Systems Discovery ST PET CT Imaging System, 510(k) Number K022872, currently in commercial distribution. Device Description: The GE Mobile Discovery ST PET CT Imaging System integrates a GE Posit…	General Electric Co.	2002	—
*	—	GE Discovery LS CT-PET System Named without a submission number			—

Also cleared against K022872: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K022872.

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 Mobile Discovery ST 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/K030199 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030199: GE Mobile Discovery ST Pet CT Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030199

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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