510(k) · Cleared

Cleared

GE CT-Pet System

K010641510(k) TraditionalCleared Mar 30, 200125-day reviewClass II21 CFR 892.1750

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

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

Cleared on Mar 30, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 494 devices in its family, counting itself, has a Class I recall. 493 later devices descend from it.

Decided: Mar 30, 2001
Review: 25 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 0

493 later devices descend from it, 4 citing it directly. 1 of the 494 devices in this family, counting this one, has a Class I recall.

This deviceK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
Descendant · cites it directly · 466 of its ownK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
Descendant · 2 generations on · 463 of its ownK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
Descendant · cites it directly · 398 of its ownK022872 GE Road Warrior Pet CT Imaging SystemGeneral Electric Co. · 2002
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

Showing 5 of 493 descendants. See all descendants

Descendants cleared per year

2001high 52 (2025) · low 1 (2001)2026

Class I recalls in this family

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

Most influential descendants

Showing 5 of 493 · See all

K023988GE Discovery LS SystemGE Medical Systems · 2003 · cites it directly466descendants
K040172Modification to GE Discovery LS SystemGE Medical Systems · 2004 · 2 generations on463descendants
K022872GE Road Warrior Pet CT Imaging SystemGeneral Electric Co. · 2002 · cites it directly398descendants
K041543GE Discovery STGE Healthcare · 2004 · 2 generations on396descendants
K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · 3 generations on380descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010641	GE CT-Pet System	Ge Medical Systems, Inc.	2001	—
+1	K023988	GE Discovery LS System	GE Medical Systems	2003	1
+2	K040172	Modification to GE Discovery LS System	GE Medical Systems	2004	5
+1	K022872	GE Road Warrior Pet CT Imaging System	General Electric Co.	2002	—
+2	K041543	GE Discovery ST	GE Healthcare	2004	1
+3	K042863	Scenium	Siemens Molecular Imaging, Ltd.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	3	0
2004	8	0
2005	4	0
2006	6	0
2007	4	0
2008	8	0
2009	1	0
2010	7	0
2011	9	0
2012	15	0
2013	10	0
2014	23	0
2015	15	0
2016	19	0
2017	22	0
2018	33	0
2019	23	0
2020	36	0
2021	33	0
2022	37	0
2023	41	0
2024	37	0
2025	52	1
2026	45	0

FIG. 1 — Lineage of K010641, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 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

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (493)

See all 493

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

Number	Device	Applicant	Decided	Descendants
K023988	GE Discovery LS System	GE Medical Systems	2003	466
K022872	GE Road Warrior Pet CT Imaging System	General Electric Co.	2002	398
K013521	Gemini Imaging System	Adac Laboratories	2001	88
K042257	Discovery ST Pet/CT Imaging System with an Alternate Detector Option	General Electric Co.	2004	14

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 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Of its descendants, K023988 (GE Medical Systems, 2003) has gone furthest, with 466 descendants of its own.

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	—

https://510kreport.com/device/K010641 · printed Nov 3, 2026

Cite this page

510(k) Report. “K010641: GE CT-Pet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010641

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026