510(k) · Cleared

Cleared

Fusion 7D

K020546510(k) TraditionalCleared Apr 26, 200266-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

Mirada Solutions, Ltd. · LLZ System, Image Processing, Radiological

Cleared on Apr 26, 2002 as substantially equivalent to K010336 (Ge Medical Systems, Inc., 2001) and 2 other predicates after a 66-day review. Its family tree reaches back 3 generations to 1996. 1 of the 449 devices in its family, counting itself, has a Class I recall. 442 later devices descend from it.

Decided: Apr 26, 2002
Review: 66 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K954678 (1996). 6 ancestors in all, the oldest K941223 (1994). 442 later devices descend from it, 9 citing it directly. 1 of the 449 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
2 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
1 generation backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
This deviceK020546 Fusion 7DMirada Solutions, Ltd. · 2002
Descendant · cites it directly · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Descendant · cites it directly · 164 of its ownK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
Descendant · 2 generations on · 143 of its ownK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
Descendant · cites it directly · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006

Showing 5 of 442 descendants. See all descendants

Descendants cleared per year

2003high 45 (2025) · low 1 (2003)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025

Most influential descendants

Showing 5 of 442 · See all

K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · cites it directly201descendants
K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
K040305VITREA2 Version 3.5Vital Images, Inc. · 2004 · cites it directly164descendants
K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · 2 generations on143descendants
K061214Aquariusaps ServerTerarecon,Inc. · 2006 · cites it directly134descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K954678	Pro Vision	Algotec Systems, Ltd.	1996	—
−2	K980648	Pro Vision	Algotec Systems, Ltd.	1998	—
−1	K992654	Plug 'N View 3D, Version 1.0	Voxar Limited	1999	—
0 (this device)	K020546	Fusion 7D	Mirada Solutions, Ltd.	2002	—
+1	K071950	Syngo Trued	Siemens Medical Solutions USA, Inc.	2007	—
+2	K091373	Syngo Trued	Siemens Medical Solutions USA, Inc.	2009	—
+1	K040305	VITREA2 Version 3.5	Vital Images, Inc.	2004	—
+2	K043333	VITREA2, Version 3.7 Medical Image Processing System	Vital Images, Inc.	2004	1
+1	K061214	Aquariusaps Server	Terarecon,Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1998	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	4	0
2005	4	0
2006	6	0
2007	8	0
2008	7	0
2009	13	0
2010	6	0
2011	6	0
2012	20	0
2013	10	0
2014	16	0
2015	18	0
2016	14	0
2017	21	0
2018	26	0
2019	24	0
2020	30	0
2021	23	0
2022	34	0
2023	33	0
2024	36	0
2025	45	1
2026	37	0

FIG. 1 — Lineage of K020546, 1996–2026Source: 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

Get a 510(k) Report

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
*	K010336	Advantage Windows CT/Pet Fusion Summary page 3 …t © Mirada Solutions Ltd, 2002 B-3 ms387-0 Fusion7D 510(k) Application Predicate Devices: 510(k) No. \| Tradename Manufacturer \| Component Applicable to K010336 Advantage Windows CT/PET \| General Anatomical to Functional Fusion Electric Registration Component K983256 Advantage Windows Fusi…	Ge Medical Systems, Inc.	2001	2
*	K983256	Advantage Windows (AW) Fusion Summary page 3 …510(k) No. \| Tradename Manufacturer \| Component Applicable to K010336 Advantage Windows CT/PET \| General Anatomical to Functional Fusion Electric Registration Component K983256 Advantage Windows Fusion General Anatomical to Anatomical Electric Registration Component K992654 Plug ‘n View 3D Voxar Visualiza…	GE Medical Systems	1998	—
*	K992654	Plug 'N View 3D, Version 1.0 Summary page 3 …General Anatomical to Functional Fusion Electric Registration Component K983256 Advantage Windows Fusion General Anatomical to Anatomical Electric Registration Component K992654 Plug ‘n View 3D Voxar Visualization Strictly Confidential Copyright © Mirada Solutions Ltd, 2002 B4 ms387-0 o f…	Voxar Limited	1999	—

Also cleared against K010336: 8 other devices →

What descends from it? (442)

See all 442

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

Number	Device	Applicant	Decided	Descendants
K071950	Syngo Trued	Siemens Medical Solutions USA, Inc.	2007	201
K040305	VITREA2 Version 3.5	Vital Images, Inc.	2004	164
K061214	Aquariusaps Server	Terarecon,Inc.	2006	134
K052305	Mri Soft Tissue Motion Correction Software VA10A	Siemens Medical Solutions USA, Inc.	2005	34
K031779	Cadstream	Confirma, Inc.	2003	19
K041286	Dynacad V1.0	Mri Devices Corp.	2004	17
K083673	Carestream Pacs, Model Carestream Pacs Vii	Carestream Health, Inc.	2008	12
K052467	Brain Viewrx Viewer, Version 1.0	Kyron Clinical Imaging, Inc.	2005	5
K060378	VITREA2 Version 3.8.1	Vital Images, Inc.	2006	1

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

What does this lineage say?

The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K071950 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 201 descendants of its own.
8 other devices also cite its predicate K010336.

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?

Read the full statement (116 words)

Fusion7D registers pairs of anatomical and functional volumetric images (e.g. MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g. MRI-MRI, CT-CT and MRI-CT) as a means to ease the comparison of image volume data by the clinician. The result of the registration operation aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared visually. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.

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/K020546 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020546: Fusion 7D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020546

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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