510(k) · Cleared

Cleared

Synapse Mip/MPR Image Visualization Software Obliquus

K061672510(k) TraditionalCleared Jun 29, 200615-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

Fujifilm Medical Systems U.S.A, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jun 29, 2006 as substantially equivalent to K040376 (Sectra-Imtec AB, 2004) after a 15-day review. Its family tree reaches back 2 generations to 2003. 12 later devices descend from it.

Decided: Jun 29, 2006
Review: 15 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K033712 (2003). 12 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK033712 Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
1 generation backK040376 Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D…Sectra-Imtec AB · 2004
This deviceK061672 Synapse Mip/MPR Image Visualization Software ObliquusFujifilm Medical Systems U.S.A, Inc. · 2006
Descendant · cites it directly · 5 of its ownK070080 IntelepacsIntelerad Medical Systems, Inc. · 2007 · Recalled
Descendant · 2 generations on · 4 of its ownK110332 Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · Recalled
Descendant · cites it directly · 2 of its ownK090649 Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation · 2009
Descendant · 3 generations on · 1 of its ownK191530 StoneCheckerImaging Biometrics, LLC · 2019
Descendant · cites it directly · 1 of its ownK100881 Synapse Obliquus Mip/MPR/FusionFujifilm Medical System U.S.A., Inc. · 2010

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2007high 2 (2009) · low 0 (2012)2026

Most influential descendants

Showing 5 of 12 · See all

K070080IntelepacsIntelerad Medical Systems, Inc. · 2007 · cites it directly5descendants
K110332Clearcanvas Ris / PacsClearcanvas, Inc. · 2011 · 2 generations on4descendants
K090649Vrad Picture Archiving and Communications System SoftwareVirtual Radiologic Corporation · 2009 · cites it directly2descendants
K191530StoneCheckerImaging Biometrics, LLC · 2019 · 3 generations on1descendant
K100881Synapse Obliquus Mip/MPR/FusionFujifilm Medical System U.S.A., Inc. · 2010 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K033712	Modification to Sectra IDS5 Radiology Workstation - Version 10.1	Sectra-Imtec AB	2003	—
−1	K040376	Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package	Sectra-Imtec AB	2004	—
0 (this device)	K061672	Synapse Mip/MPR Image Visualization Software Obliquus	Fujifilm Medical Systems U.S.A, Inc.	2006	—
+1	K070080	Intelepacs	Intelerad Medical Systems, Inc.	2007	2
+2	K110332	Clearcanvas Ris / Pacs	Clearcanvas, Inc.	2011	1
+1	K090649	Vrad Picture Archiving and Communications System Software	Virtual Radiologic Corporation	2009	—
+3	K191530	StoneChecker	Imaging Biometrics, LLC	2019	—
+1	K100881	Synapse Obliquus Mip/MPR/Fusion	Fujifilm Medical System U.S.A., Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	2	0
2010	1	0
2011	1	0
2013	1	0
2017	1	0
2018	1	0
2019	1	0
2021	1	0
2023	1	0

FIG. 1 — Lineage of K061672, 2003–2023Source: 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 LLZ? 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? (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
*	K040376	Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package Summary page 1 …Received: TBD Decision Date: TBD Decision: TBD Predicate Device Sectra IDS5 Radiology Workstation with Sectra 3D and MPR packages 510(k) #: K040376, cleared by CDRH on 05/04/04 9…	Sectra-Imtec AB	2004	—

Also cleared against K040376: 6 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K070080	Intelepacs	Intelerad Medical Systems, Inc.	2007	5
K090649	Vrad Picture Archiving and Communications System Software	Virtual Radiologic Corporation	2009	2
K100881	Synapse Obliquus Mip/MPR/Fusion	Fujifilm Medical System U.S.A., Inc.	2010	1
K081215	Volumina	Kjaya Medical, LLC	2008	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 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K070080 (Intelerad Medical Systems, Inc., 2007) has gone furthest, with 5 descendants of its own.
6 other devices also cite its predicate K040376.

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?

Synapse Image Visualization Software MIP/MPR Obliquus enables the display of 3D (MIP/MPR) visualization of CT and MR studies. Typical users are radiologista, technologists and clinicians.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061672 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061672: Synapse Mip/MPR Image Visualization Software Obliquus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061672

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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