510(k) · Cleared

Recalled · Class II · 2015

Genesys II

K922080510(k) TraditionalCleared Jul 17, 199274-day reviewClass II21 CFR 892.1200Recalls 2

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

Adac Laboratories · KPS System, Tomography, Computed, Emission

Cleared on Jul 17, 1992 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 19 devices in its family, counting itself, has a Class I recall. 18 later devices descend from it. It has been recalled 2 times.

Decided: Jul 17, 1992
Review: 74 days
Class: Class II
Product code: KPS
Recalls: 2
Predicates: 0

18 later devices descend from it, 2 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.

This deviceK922080 Genesys IIAdac Laboratories · 1992
Descendant · cites it directly · 16 of its ownK962738 Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · Recalled (Class I)
Descendant · 2 generations on · 11 of its ownK022240 Mobile Millennium MG SystemGe Medical Systems, Inc. · 2002
Descendant · 3 generations on · 10 of its ownK090811 Inspira HD, Model: NL1000Neurologica Corporation · 2009
Descendant · 4 generations on · 9 of its ownK102677 Bodytom NL 4000Neurologica Corporation · 2011
Descendant · 5 generations on · 4 of its ownK170238 BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

1996high 2 (2008) · low 0 (1997)2026

Class I recalls in this family

K962738 Millennium MT and Millennium MG Nuclear Medicine…cites it directly · 1996

Most influential descendants

Showing 5 of 18 · See all

K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · cites it directly16descendants
K022240Mobile Millennium MG SystemGe Medical Systems, Inc. · 2002 · 2 generations on11descendants
K090811Inspira HD, Model: NL1000Neurologica Corporation · 2009 · 3 generations on10descendants
K102677Bodytom NL 4000Neurologica Corporation · 2011 · 4 generations on9descendants
K170238BodyTom EliteNeurologica Corporation, A Subsidiary of Samsung Electronics · 2017 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K922080	Genesys II	Adac Laboratories	1992	—
+1	K962738	Millennium MT and Millennium MG Nuclear Medicine Systems	GE Medical Systems	1996	Class I
+2	K022240	Mobile Millennium MG System	Ge Medical Systems, Inc.	2002	—
+3	K090811	Inspira HD, Model: NL1000	Neurologica Corporation	2009	—
+4	K102677	Bodytom NL 4000	Neurologica Corporation	2011	—
+5	K170238	BodyTom Elite	Neurologica Corporation, A Subsidiary of Samsung Electronics	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	1
2002	1	0
2005	1	0
2007	1	0
2008	2	0
2009	1	0
2011	1	0
2013	1	0
2014	1	0
2016	1	0
2017	1	0
2018	1	0
2021	1	0
2022	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K922080, 1992–2026Source: 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 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

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? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K962738	Millennium MT and Millennium MG Nuclear Medicine Systems Class I	GE Medical Systems	1996	16
K073021	Multi-Spect	Eagle Heart Imaging, LLC	2007	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 13, 2015	Class II	Z-1598-2015	Employee error	During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.
Mar 10, 2014	Class II	Z-1510-2014	Device Design	Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.

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.

K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · Cites it directly · ◆ in the 1996 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

Of its descendants, K962738 (GE Medical Systems, 1996) has gone furthest, with 16 descendants of its own.

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	—

https://510kreport.com/device/K922080 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922080: Genesys II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922080

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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