510(k) · Cleared
ClearedOlea Sphere
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olea Medical · LLZ System, Image Processing, Radiological
Cleared on Dec 26, 2013 as substantially equivalent to K120196 (Olea Medical, 2012) after a 171-day review. Its family tree reaches back 10 generations to 1990. 20 later devices descend from it.
- Decided
- Dec 26, 2013
- Review
- 171 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K896095 (1990). 11 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations between
- 3 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 2 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 1 generation backK120196 Olea SphereOlea Medical · 2012
- This deviceK132095 Olea SphereOlea Medical · 2013
- Descendant · cites it directly · 17 of its ownK152602 Olea Sphere V3.0Olea Medical · 2016
- Descendant · 2 generations on · 1 of its ownK223532 Olea S.I.A. Neurovascular V1.0Olea Medical · 2023
- Descendant · 2 generations on · 1 of its ownK211059 CereFlow™ V1.2Translational Mri, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK212565 CoverScan v1Perspectum, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK203582 QUIBIM Precision Prostate (qp-Prostate)Quibim S.L. · 2021
Show all 10 generations
- Root · 10 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 9 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 8 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 7 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 6 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 5 generations backK063539 Nordic Image Control and Evaluation (Nice) Software, Version 2.1Nordicicemedical AS · 2007
- 4 generations backK082441 Nordicice SoftwareNordicimaginglab AS · 2008 · Recalled
- 3 generations backK090546 Modification to Nordicice SoftwareNordicimaginglab AS · 2009
- 2 generations backK111161 Perfscape V2.0Olea Medical · 2011
- 1 generation backK120196 Olea SphereOlea Medical · 2012
- This deviceK132095 Olea SphereOlea Medical · 2013
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K152602Olea Sphere V3.0Olea Medical · 2016 · cites it directly17descendants
- K223532Olea S.I.A. Neurovascular V1.0Olea Medical · 2023 · 2 generations on1descendant
- K211059CereFlow™ V1.2Translational Mri, LLC · 2023 · 2 generations on1descendant
- K212565CoverScan v1Perspectum, Ltd. · 2022 · 2 generations on1descendant
- K203582QUIBIM Precision Prostate (qp-Prostate)Quibim S.L. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −9 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −8 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −7 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −6 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −5 | K063539 | Nordic Image Control and Evaluation (Nice) Software, Version 2.1 | Nordicicemedical AS | 2007 | — |
| −4 | K082441 | Nordicice Software | Nordicimaginglab AS | 2008 | 2 |
| −3 | K090546 | Modification to Nordicice Software | Nordicimaginglab AS | 2009 | — |
| −2 | K111161 | Perfscape V2.0 | Olea Medical | 2011 | — |
| −1 | K120196 | Olea Sphere | Olea Medical | 2012 | — |
| 0 (this device) | K132095 | Olea Sphere | Olea Medical | 2013 | — |
| +1 | K152602 | Olea Sphere V3.0 | Olea Medical | 2016 | — |
| +2 | K223532 | Olea S.I.A. Neurovascular V1.0 | Olea Medical | 2023 | — |
| +2 | K211059 | CereFlow™ V1.2 | Translational Mri, LLC | 2023 | — |
| +2 | K212565 | CoverScan v1 | Perspectum, Ltd. | 2022 | — |
| +2 | K203582 | QUIBIM Precision Prostate (qp-Prostate) | Quibim S.L. | 2021 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (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 | Decided |
|---|---|---|---|
| * | K120196 | Olea Sphere Our OCR of the scanned summary read K120186, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Olea Sphere”. | 2012 |
What descends from it? (20)
See all 203 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K152602 (Olea Medical, 2016) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K120196.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf” workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. Olea Sphere provides both viewing and analysis capabilities of functional…
Read the full statement (217 words)
Olea Sphere is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf” workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.
Olea Sphere provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including a Diffusion Weighted MRI (DWI1) / Fiber Tracking Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT),
The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Fiber Tracking feature utilizes the directional dependency of the diffusion to display the white matter structure in the brain or more generally the central nervous system.
The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary. This functionality is referred to as:
Perfusion Module — the calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Permeability Module — the calculation of parameters related to leakage of injected contrast material from intravascular to extracellular space.
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/K132095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132095: Olea Sphere.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132095
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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