510(k) · Cleared

Cleared

Mirage

K972886510(k) TraditionalCleared Oct 1, 199757-day reviewClass II21 CFR 892.2050

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

Segami Corp., Inc. · LLZ System, Image Processing, Radiological

Cleared on Oct 1, 1997 as substantially equivalent to K914350 (Siemens Gammasonics, Inc., 1991) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 1991. 1 of the 416 devices in its family, counting itself, has a Class I recall. 413 later devices descend from it.

Decided: Oct 1, 1997
Review: 57 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K914350 (1991). 2 ancestors in all. 413 later devices descend from it, 4 citing it directly. 1 of the 416 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK914350 Icon Computer SystemSiemens Gammasonics, Inc. · 1991 · Recalled
This deviceK972886 MirageSegami Corp., Inc. · 1997
Descendant · cites it directly · 382 of its ownK041022 Neuroq - Pet DPSyntermed, Inc. · 2004
Descendant · 2 generations on · 380 of its ownK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
Descendant · 2 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
Descendant · 3 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009

Showing 5 of 413 descendants. See all descendants

Descendants cleared per year

2004high 42 (2025) · low 2 (2004)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025

Most influential descendants

Showing 5 of 413 · See all

K041022Neuroq - Pet DPSyntermed, Inc. · 2004 · cites it directly382descendants
K042863SceniumSiemens Molecular Imaging, Ltd. · 2004 · 2 generations on380descendants
K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 2 generations on350descendants
K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 3 generations on287descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914350	Icon Computer System	Siemens Gammasonics, Inc.	1991	1
0 (this device)	K972886	Mirage	Segami Corp., Inc.	1997	—
+1	K041022	Neuroq - Pet DP	Syntermed, Inc.	2004	—
+2	K042863	Scenium	Siemens Molecular Imaging, Ltd.	2004	—
+2	K060816	Mim 4.0 (Neuro	Mimvista Corp.	2006	1
+3	K071964	Mim 4.1 (Seastar)	Mimvista Corp.	2007	2
+4	K091373	Syngo Trued	Siemens Medical Solutions USA, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	2	0
2006	6	0
2007	7	0
2008	8	0
2009	3	0
2010	7	0
2011	9	0
2012	10	0
2013	9	0
2014	14	0
2015	13	0
2016	18	0
2017	18	0
2018	28	0
2019	24	0
2020	32	0
2021	27	0
2022	32	0
2023	34	0
2024	30	0
2025	42	1
2026	38	0

FIG. 1 — Lineage of K972886, 1991–2026Source: 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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? (2)

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
*	K914350	Icon Computer System Summary page 2 …: MIRAGE 10.3. Substantial Equivalence (Predicate devices) The predicate devices are the ICON COMPUTER SYSTEM by Siemens Medical Systems, Inc.(Product code JWM, 510K # K914350) and SOPHY NXT by Sopha Medical Systems, Inc.(product code KPS and 501K# K913641). Substantial equivalence was shown non-clinica…	Siemens Gammasonics, Inc.	1991	1
*	K913641	Sophy NXT Summary page 2 …s are the ICON COMPUTER SYSTEM by Siemens Medical Systems, Inc.(Product code JWM, 510K # K914350) and SOPHY NXT by Sopha Medical Systems, Inc.(product code KPS and 501K# K913641). Substantial equivalence was shown non-clinically by demonstrating that Generic Image Operations, Generic Tomographic post-pro…	Sopha Medical Systems, Inc.	1991	—

Also cleared against K914350: 2 other devices →

What descends from it? (413)

See all 413

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

Number	Device	Applicant	Decided	Descendants
K041022	Neuroq - Pet DP	Syntermed, Inc.	2004	382
K053062	Cardiarc Spect Imaging Device, Model CQ103-RV2	Cardiarc, Ltd.	2006	16
K050815	Xact.Cardiac & Xpress.Cardiac	Ultraspect, Ltd.	2005	14
K052430	Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System	Digirad Corp.	2005	7

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

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K041022 (Syntermed, Inc., 2004) has gone furthest, with 382 descendants of its own.
2 other devices also cite its predicate K914350.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

The Mirage system is indicated for the acquisition, formatting and storage of scintigraphy

camera output data. 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972886 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972886: Mirage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972886

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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