510(k) · Cleared

Cleared

Syntegra

K041182510(k) TraditionalCleared May 21, 200415-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

Adac Laboratories · KPS System, Tomography, Computed, Emission

Cleared on May 21, 2004 as substantially equivalent to K032036 (Philips Medical Systems (Cleveland), Inc., 2003) after a 15-day review. Its family tree reaches back 5 generations to 1993. 20 later devices descend from it.

Decided: May 21, 2004
Review: 15 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K930090 (1993). 13 ancestors in all. 20 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
1 generation backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
This deviceK041182 SyntegraAdac Laboratories · 2004
Descendant · cites it directly · 11 of its ownK061671 Syngo Trued, Model VC10ASiemens Medical Solutions · 2006
Descendant · 2 generations on · 9 of its ownK071241 LMS-LiverMedian Technologies · 2007
Descendant · 3 generations on · 8 of its ownK121213 VitreaadvancedVital Images, Inc. · 2012 · Recalled
Descendant · cites it directly · 7 of its ownK081987 Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions · 2008
Descendant · 4 generations on · 5 of its ownK142521 Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2006high 3 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 20 · See all

K061671Syngo Trued, Model VC10ASiemens Medical Solutions · 2006 · cites it directly11descendants
K071241LMS-LiverMedian Technologies · 2007 · 2 generations on9descendants
K121213VitreaadvancedVital Images, Inc. · 2012 · 3 generations on8descendants
K081987Unisyn Image Fusion, Version 1.0Convergent Imaging Solutions · 2008 · cites it directly7descendants
K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc. · 2014 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K930090	Helicat	Elscint, Inc.	1993	—
−4	K961464	Select/SP	Elscint, Inc.	1996	3
−3	K982060	Volumax CT Imaging System	Elscint, Inc.	1998	—
−2	K012009	MX8000 Idt CT System	Marconi Medical Systems, Inc.	2001	61
−1	K032036	Gemini 16	Philips Medical Systems (Cleveland), Inc.	2003	2
0 (this device)	K041182	Syntegra	Adac Laboratories	2004	—
+1	K061671	Syngo Trued, Model VC10A	Siemens Medical Solutions	2006	—
+2	K071241	LMS-Liver	Median Technologies	2007	—
+3	K121213	Vitreaadvanced	Vital Images, Inc.	2012	1
+1	K081987	Unisyn Image Fusion, Version 1.0	Convergent Imaging Solutions	2008	—
+4	K142521	Synapse 3D Liver and Kidney Analysis	Fujifilm Meidcal Systems U.S.A.,Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	1	0
1997	1	0
2000	1	0
2001	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	2	0
2012	2	0
2014	2	0
2015	1	0
2016	2	0
2018	1	0
2021	2	0
2023	3	0
2024	1	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K041182, 1993–2026Source: 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.

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? (1)

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
*	K032036	Gemini 16 Summary page 1 …: Manufacturer Product Name 510(k) No. Philips Medical Systems Gemini 16 K032036 E. Intended Use: SyntegraT rm is a software application for multi-modality image registration and diagnostic fusion. Image…	Philips Medical Systems (Cleveland), Inc.	2003	2

Also cleared against K032036: 1 other device →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K061671	Syngo Trued, Model VC10A	Siemens Medical Solutions	2006	11
K081987	Unisyn Image Fusion, Version 1.0	Convergent Imaging Solutions	2008	7
K120187	Multi-Modality Image Fusion	Igt, LLC Dba Eigen	2012	4
K140033	TARGET3D Fusion	Convergent Life Sciences, Inc.	2014	0

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?

The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
6 of the 13 ancestors have a recall of any class.
Of its descendants, K061671 (Siemens Medical Solutions, 2006) has gone furthest, with 11 descendants of its own.
1 other device also cites its predicate K032036.

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?

SyntegraTM is a software application for multi-modality image registration and

diagnostic fusion. Images are registered and displayed in a "fused" (overlaid in the

same spatial orientation) format to provide combined functional and anatomical data

providing different angular perspectives for interpretation by trained professionals

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041182 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041182: Syntegra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041182

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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