510(k) · Cleared

Cleared

Mirage, Release 5.5

K043441510(k) SpecialCleared Jan 13, 200530-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

Segami Corporation · KPS System, Tomography, Computed, Emission

Cleared on Jan 13, 2005 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 98 later devices descend from it.

Decided: Jan 13, 2005
Review: 30 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 0

98 later devices descend from it, 4 citing it directly.

This deviceK043441 Mirage, Release 5.5Segami Corporation · 2005
Descendant · cites it directly · 91 of its ownK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
Descendant · cites it directly · 90 of its ownK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
Descendant · cites it directly · 79 of its ownK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
Descendant · 2 generations on · 77 of its ownK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
Descendant · 3 generations on · 60 of its ownK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016

Showing 5 of 98 descendants. See all descendants

Descendants cleared per year

2006high 12 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 98 · See all

K061545Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006 · cites it directly91descendants
K121074Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012 · cites it directly90descendants
K123528SceniumSiemens Medical Solutions USA, Inc. · 2012 · cites it directly79descendants
K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013 · 2 generations on77descendants
K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016 · 3 generations on60descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K043441	Mirage, Release 5.5	Segami Corporation	2005	—
+1	K061545	Scenium 1.1	Siemens Molecular Imaging, Ltd.	2006	—
+1	K121074	Scenium 2.0	Siemens Medical Solutions USA, Inc.	2012	—
+1	K123528	Scenium	Siemens Medical Solutions USA, Inc.	2012	—
+2	K130884	Xeleris 3.1 Processing and Review Workstation	Ge Medical Systems F.I. Haifa	2013	—
+3	K153355	Xeleris 4.0 Processing and Review Workstation	GE Healthcare	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0
2011	1	0
2012	2	0
2013	2	0
2014	4	0
2015	3	0
2016	5	0
2017	3	0
2018	4	0
2019	2	0
2020	7	0
2021	9	0
2022	10	0
2023	11	0
2024	10	0
2025	12	0
2026	11	0

FIG. 1 — Lineage of K043441, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 18.6 · 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (98)

See all 98

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

Number	Device	Applicant	Decided	Descendants
K061545	Scenium 1.1	Siemens Molecular Imaging, Ltd.	2006	91
K121074	Scenium 2.0	Siemens Medical Solutions USA, Inc.	2012	90
K123528	Scenium	Siemens Medical Solutions USA, Inc.	2012	79
K080013	Registration and Fusion	Agfa Healthcare Corporation	2008	5

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?

Of its descendants, K061545 (Siemens Molecular Imaging, Ltd., 2006) has gone furthest, with 91 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	—

What is it indicated for?

The Mirage Release 5.5 system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K043441 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043441: Mirage, Release 5.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043441

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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