510(k) · Cleared

Recalled · 2003

GE Discovery LS System

K023988510(k) TraditionalCleared Feb 4, 200364-day reviewClass II21 CFR 892.1200Recalls 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 · KPS System, Tomography, Computed, Emission

Cleared on Feb 4, 2003 as substantially equivalent to K010641 (Ge Medical Systems, Inc., 2001) after a 64-day review. Its family tree reaches back 1 generation to 2001. 1 of the 468 devices in its family, counting itself, has a Class I recall. 466 later devices descend from it. It has been recalled once.

Decided: Feb 4, 2003
Review: 64 days
Class: Class II
Product code: KPS
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K010641 (2001). 466 later devices descend from it, 2 citing it directly. 1 of the 468 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 deviceK023988 GE Discovery LS SystemGE Medical Systems · 2003
Descendant · cites it directly · 463 of its ownK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
Descendant · 2 generations on · 396 of its ownK041543 GE Discovery STGE Healthcare · 2004 · Recalled
Descendant · 3 generations on · 380 of its ownK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
Descendant · 4 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
Descendant · 5 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled

Showing 5 of 466 descendants. See all descendants

Descendants cleared per year

2004high 51 (2025) · low 1 (2009)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…11 generations on · 2025

Most influential descendants

Showing 5 of 466 · See all

K040172Modification to GE Discovery LS SystemGE Medical Systems · 2004 · cites it directly463descendants
K041543GE Discovery STGE Healthcare · 2004 · 2 generations on396descendants
K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · 3 generations on380descendants
K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 4 generations on350descendants
K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 5 generations on287descendants

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)	K023988	GE Discovery LS System	GE Medical Systems	2003	—
+1	K040172	Modification to GE Discovery LS System	GE Medical Systems	2004	5
+2	K041543	GE Discovery ST	GE Healthcare	2004	1
+3	K042863	Scenium	Siemens Molecular Imaging, Ltd.	2004	—
+4	K060816	Mim 4.0 (Neuro	Mimvista Corp.	2006	1
+5	K071964	Mim 4.1 (Seastar)	Mimvista Corp.	2007	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	6	0
2005	4	0
2006	5	0
2007	3	0
2008	6	0
2009	1	0
2010	7	0
2011	9	0
2012	13	0
2013	10	0
2014	21	0
2015	14	0
2016	17	0
2017	22	0
2018	32	0
2019	23	0
2020	36	0
2021	31	0
2022	37	0
2023	38	0
2024	36	0
2025	51	1
2026	44	0

FIG. 1 — Lineage of K023988, 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 18.7 · 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? (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 2 …ET System is substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery LS CT-PET System, 51O(k) No. K010641. 6 4 Ci*j'-4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public He…	Ge Medical Systems, Inc.	2001	—

Also cleared against K010641: 3 other devices →

What descends from it? (466)

See all 466

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

Number	Device	Applicant	Decided	Descendants
K040172	Modification to GE Discovery LS System	GE Medical Systems	2004	463
K050366	Imagenpro	Cardiovascular Imaging Technologies, LLC	2005	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
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.

K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 11 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, K040172 (GE Medical Systems, 2004) has gone furthest, with 463 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 Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the…

Read the full statement (119 words)

The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation and diagnosis of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This can also assist in radiotherapy planning.

The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023988 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023988: GE Discovery LS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023988

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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