510(k) · Cleared

Cleared

Infinia Lightspeed

K043381510(k) TraditionalCleared Dec 23, 200414-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

Ge Medical Systems F.I. Haifa · KPS System, Tomography, Computed, Emission

Cleared on Dec 23, 2004 as substantially equivalent to K022960 (Ge Medical Systems F.I. Haifa, 2002) and 2 other predicates after a 14-day review. Its family tree reaches back 4 generations to 1995. 3 of the 10 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Dec 23, 2004
Review: 14 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K952674 (1995). 8 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
3 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
2 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
1 generation backK022960 GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Recalled (Class I)
This deviceK043381 Infinia LightspeedGe Medical Systems F.I. Haifa · 2004
Descendant · cites it directly · 0 of its ownK083504 GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa · 2008 · Recalled

Class I recalls in this family

K022960 GE Quasar Nuclear Medicine Systemdirect predicate · 2002
K991841 Hawkeye Option for Dual-Head Variable Angle…direct predicate · 1999
K953801 Varicam2 generations back · 1995

Most influential descendants

Showing 1 of 1 · See all

K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	1995	1
−3	K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma…	Ge Medical Systems F.I. Haifa	1998	—
−2	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera	Ge Medical Systems F.I. Haifa	1999	Class I
−1	K022960	GE Quasar Nuclear Medicine System	Ge Medical Systems F.I. Haifa	2002	Class I
0 (this device)	K043381	Infinia Lightspeed	Ge Medical Systems F.I. Haifa	2004	—
+1	K083504	GE Discovery NM/CT 570C	Ge Medical Systems F.I. Haifa	2008	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	1
1997	1	0
2001	1	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K043381, 1995–2008Source: 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.

3 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 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? (3)

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
*	K022960	GE Quasar Nuclear Medicine System Summary page 1 …of legally marketed devices. Identification of Legally Marketed Equivalent Devices GE Quasar Nuclear Medicine System ("Infinia") K022960 "LightSpeed" 5.0 Computed Tomography System K030420 Hawkeye Option for Dual Head Variab…	Ge Medical Systems F.I. Haifa	2002	Class I
*	K030420	Lightspeed 5.0 Computed Tomography System Summary page 1 …s GE Quasar Nuclear Medicine System ("Infinia") K022960 "LightSpeed" 5.0 Computed Tomography System K030420 Hawkeye Option for Dual Head Variable Angle Gamma Camera K99 1841 Device Description The "Inf…	GE Medical Systems	2003	4
*	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera Summary page 1 …0 "LightSpeed" 5.0 Computed Tomography System K030420 Hawkeye Option for Dual Head Variable Angle Gamma Camera K99 1841 Device Description The "Infinia LightSpeed" system is a combination of the Infinia NM Scanner (K022960 & K991…	Ge Medical Systems F.I. Haifa	1999	Class I

Also cleared against K022960: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K083504	GE Discovery NM/CT 570C	Ge Medical Systems F.I. Haifa	2008	0

Has anything in its family been recalled? (3 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.

K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K953801VaricamElscint, Inc. · 1995 · 2 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
6 of the 8 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K083504 (Ge Medical Systems F.I. Haifa, 2008) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K022960.

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 intended use of the "Infinia LightSpeed" system is to perform:

General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.

General Head & Body computed tomography (CT) applications.

Combined, hybrid SPECT & CT protocols, for CT-based SPECT attenuation correction imaging as well as functional and anatomical mapping imaging (registration and fusion).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043381 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043381: Infinia Lightspeed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043381

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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