510(k) · Cleared
ClearedSynapse Obliquus Mip/MPR/Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 14, 2010 as substantially equivalent to K061672 (Fujifilm Medical Systems U.S.A, Inc., 2006) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it.
- Decided
- Apr 14, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K033712 (2003). 4 ancestors in all, the oldest K010336 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK033712 Modification to Sectra IDS5 Radiology Workstation - Version 10.1Sectra-Imtec AB · 2003
- 2 generations backK040376 Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D…Sectra-Imtec AB · 2004
- 1 generation backK061672 Synapse Mip/MPR Image Visualization Software ObliquusFujifilm Medical Systems U.S.A, Inc. · 2006
- This deviceK100881 Synapse Obliquus Mip/MPR/FusionFujifilm Medical System U.S.A., Inc. · 2010
- Descendant · cites it directly · 0 of its ownK124048 ImagequbeIntuitive Imaging Informatics, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K124048ImagequbeIntuitive Imaging Informatics, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033712 | Modification to Sectra IDS5 Radiology Workstation - Version 10.1 | Sectra-Imtec AB | 2003 | — |
| −2 | K040376 | Sectra IDS5 Radiology Workstation; Sectra MPR Package; Sectra 3D Package | Sectra-Imtec AB | 2004 | — |
| −1 | K061672 | Synapse Mip/MPR Image Visualization Software Obliquus | Fujifilm Medical Systems U.S.A, Inc. | 2006 | — |
| 0 (this device) | K100881 | Synapse Obliquus Mip/MPR/Fusion | Fujifilm Medical System U.S.A., Inc. | 2010 | — |
| +1 | K124048 | Imageqube | Intuitive Imaging Informatics, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K061672 | Synapse Mip/MPR Image Visualization Software ObliquusSummary page 1…lass: Class II Product Code: LLZ Substantial Equivalence/Predicate Devices: Synapse 3D (MIP/MPR) Image Visualization Software OBLIQIJUS - K061672 GE Advantage Windows CT/PET Fusion - K010336 Synapse Obliquus MIP/MPR/Fusion Software and the predicate Synapse 3D (MIP/M… | 2006 |
| * | K010336 | Advantage Windows CT/Pet FusionSummary page 1…LLZ Substantial Equivalence/Predicate Devices: Synapse 3D (MIP/MPR) Image Visualization Software OBLIQIJUS - K061672 GE Advantage Windows CT/PET Fusion - K010336 Synapse Obliquus MIP/MPR/Fusion Software and the predicate Synapse 3D (MIP/MPR) linage Visualization software OBLIQUUS (K… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124048 | Imageqube | 2013 | 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 7 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K124048 (Intuitive Imaging Informatics, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K061672.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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 Obliquus MIP/MPS/Fusion software enables the display of 3D (MIP/MPR).visualization of CT, MR and PET studies and fusion or blending of CT and PET studies. Typical users are radiologists, technologists, and clinicians.
Obliquus is not intended for mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100881: Synapse Obliquus Mip/MPR/Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100881
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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